Treatment Trials

158 Clinical Trials for Various Conditions

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RECRUITING
Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes
Description

Patients with digestive tract malignancy often experience severe and unremitting abdominal pain that negatively affects physical, emotional, and social function, as well as health related quality of life (HRQOL). Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for cancer pain. Users of VR wear a pair of goggles with a close-proximity screen in front of the eyes that creates a sensation of being transported into lifelike, three-dimensional worlds. To date, VR has been limited to short-term clinical trials for cancer pain. Moreover, limited research exists on theory-based VR modalities beyond mere distraction, such as VR that employs acceptance and commitment therapy (ACT) with components of biofeedback and mindfulness. To bridge these gaps, this study seeks to: (1) assess the impact of immersive VR on patient-reported outcomes (PROs), including pain, activity metrics, and opioid use among patients with visceral pain from a digestive tract malignancy; (2) assess differences in PROs, activity metrics, and opioid use between skills-based VR therapy vs. distraction VR therapy; and (3) determine patient-level predictors of VR treatment response in visceral cancer pain. To address these aims, the study will measure PROs and opioid use in 360 patients randomized among 3 groups and follow them for 60 days after enrollment: (1) an enhanced VR group receiving skills-based VR; (2) a distraction-based VR group receiving patient-selected VR videos; and (3) a VR sham control group using a VR headset with 2-D content. The results will inform best practices for the implementation of VR for visceral cancer pain management and guide selection of patient-tailored experiences.

Conditions
Cancer PainVisceral PainGastrointestinal NeoplasmsCancer of Gastrointestinal TractSmall Intestine CancerPancreas CancerLiver CancerColon CancerBiliary Tract CancerStomach CancerRectum CancerPeritoneal CancerGastrointestinal Cancer MetastaticGastrointestinal Cancers - AnusGastrointestinal Cancers - StomachGastrointestinal Cancers - ColorectalGastrointestinal Cancers - Small IntestineSmall Intestine Cancer Stage IIISmall Intestine Cancer Stage IVSmall Intestine Cancer, RecurrentPancreas Cancer, Stage IIIPancreas Cancer, Stage IVPancreas Cancer, MetastaticPancreas Cancer, RecurrentLiver Cancer Stage IIIaLiver Cancer Stage IIIbLiver Cancer Stage IIIcLiver Cancer Stage IVColon Cancer Stage IIIColon Cancer Stage IVStomach Cancer Stage IIIStomach Cancer Stage IVStomach Cancer RecurrentRectum Cancer, RecurrentGastrointestinal Cancers - LiverAnal CancerAnal Cancer Stage IIIAnal Cancer Stage IVAnal Cancer RecurrentAnal Cancer MetastaticAnal Cancer, Stage IIIAAnal Cancer, Stage IIIBAppendix CancerAmpullary CancerBile Duct CancerBile Duct Cancer Stage IIIBile Duct Cancer Stage IVBile Duct Cancer Stage IVABile Duct Cancer Stage IVBBile Duct Cancer RecurrentCarcinoid TumorCarcinoid Tumor of PancreasCarcinoid Tumor of Large IntestineCarcinoid Tumor of GI SystemCarcinoid Tumor of ColonCarcinoid Tumor of LiverCarcinoid Tumor of CecumCarcinoid Tumor of IleumCarcinoid Tumor of RectumCarcinoid Tumor of the Small BowelCarcinoid Tumor of the StomachLarge Intestine CancerEsophagus CancerEsophagus Cancer, Stage IIIEsophagus Cancer, Stage IVEsophagus Cancer, RecurrentGallbladder CancerGallbladder Cancer Stage IIIGallbladder Cancer Stage IVGastric (Stomach) CancerNeuroendocrine TumorPeritoneum CancerRectal CancerEsophagus Cancer, Stage IEsophagus Cancer, Stage IIGallbladder Cancer Stage IGallbladder Cancer Stage IIBile Duct Cancer Stage IBile Duct Cancer Stage II
TERMINATED
A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC)
Description

The purpose of this study is to evaluate the safety of TAK-164 and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) and schedule.

RECRUITING
Tissue Procurement for Gastric Cancer, Gastrointestinal Stromal Tumors (GIST), Esophageal Cancer, Pancreas Cancer, Hepatocellular Cancer, Biliary Cancer, Neuroendocrine, Peritoneal Mesothelioma, Anal Cancer and Colorectal Cancer in Patients Undergoing Surgery or Biopsy
Description

The purpose of this study is to collect and store normal and malignant tissue from patients with gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer, an estimated 50 to 100 of each tumor type. To collect and store blood samples from patients with gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer. To create a database for the collected tissue and allow access to relevant clinical information for current and future protocols. To create tissue microarrays for each gastrointestinal cancer subtype, namely, gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer, to facilitate future molecular studies. To grant access to Dr Kindler, Dr. Salgia, and Dr. Catenacci to this database (as it is being acquired) of the coupled patient tissue samples (normal and malignant) and relevant clinical information for the investigation of tyrosine kinases, such as Met and Ron, receptor tyrosine kinase family members, STATs, paxillin, focal adhesion proteins, cell motility/migration proteins, tyrosine/serine/threonine kinase family members, related molecules, and downstream targets implicated in the pathogenesis of GI cancers. Examples of molecular testing include evaluation of DNA mutation, alternative splice variants, protein expression and phosphorylation, and immunohistochemistry on samples. These studies will be correlated with clinical information as stated above.

Conditions
TERMINATED
Evaluation of Patients With Bulky GIST Using Sunitinib
Description

The primary purpose of this study is to determine if oral (mouth) delivery prior to tumor removal in patients with gastrointestinal stromal tumor (GIST) results in tumor shrinkage allowing for successful surgery. Therapy will be administered orally and the response of the tumor will be assessed using CTs or MRIs.

Conditions
TERMINATED
Assessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers
Description

The purpose of the study is to determine whether standardized implementation of a scripted template for discussing important issues that arise near the end of life improves the care of those who have advanced cancer.

WITHDRAWN
A Phase I Study of Adagrasib and Durvalumab for Treatment of Advanced Non-small Cell Lung Cancers and Gastro-intestinal Cancers Harboring KRAS G12C Mutations
Description

To find a recommended dose of the combination of adagrasib and durvalumab that can be given to patients with cancers that have a KRAS G12C mutation.

COMPLETED
The GI Binder: A Psychoeducational Intervention for Gastrointestinal Cancer Patients
Description

This research study is evaluating the use of a binder of educational materials with nurse teaching to prepare patients for chemotherapy

RECRUITING
sFOLFOXIRI in Advanced Gastroesophageal Cancer, (SAGE)
Description

The primary objective is to determine the clinical efficacy of treatment regimen in terms of objective response rate (ORR). The secondary objectives is to determine the clinical efficacy of the study treatment in terms of progression free survival (PFS) and overall survival (OS). Additionally, to characterize the safety and toxicity profile of the study treatment as measured by the adverse event rates.

COMPLETED
Combination of Brivanib With 5-Fluorouracil/Leucovorin (5FU/LV) and 5-Fluorouracil/Leucovorin/Irinotecan (FOLFIRI)
Description

The purpose of this study is to determine a safe and maximum tolerable dose of Brivanib when combined with standard dose 5FU/LV and FOLFIRI.

RECRUITING
Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression
Description

This clinical trial is evaluating a drug called BT5528 alone and in combination with nivolumab in participants with advanced solid tumors historically known for expression of EphA2. The main goals of this study are to: * Find the recommended dose(s) of BT5528 that can be given safely to participants alone and in combination with nivolumab * Learn more about the side effects of BT5528 * Learn about how effective BT5528 is for the treatment of ovarian cancer, urothelial/bladder cancer, lung cancer (NSCLC), triple-negative breast cancer, head and neck cancer (HNSCC), and gastric/upper gastrointestinal cancer. * Learn more about BT5528 therapy alone and in combination with nivolumab.

TERMINATED
Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)
Description

Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST)

ACTIVE_NOT_RECRUITING
Testing the Anti-cancer Drug, Rogaratinib (BAY 1163877), for Treatment of Advanced Sarcoma With Alteration in Fibroblast Growth Factor Receptor (FGFR 1-4), and in Patients With SDH-deficient Gastrointestinal Stromal Tumor (GIST)
Description

This phase II trial studies the effect of rogaratinib in treating patients with sarcoma with a change in a group of proteins called fibroblast growth factor receptors (FGFRs) or SDH-deficient gastrointestinal stromal tumor (GIST). Rogaratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

RECRUITING
EQUITY GI: A Prospective Study to Enhance Quality, Inclusivity, and Trial Participation in Black Patients With Gastrointestinal Cancer.
Description

This research study is being conducted to improve the quality of care of participants who have a diagnosis of gastrointestinal cancer (anal, colon, rectal, esophageal, stomach, small bowel, appendix, pancreas, gall bladder, liver, neuroendocrine tumor of gastrointestinal origin). This study has 3 components as follows- 1. Ensuring appropriate biomarker testing and evidence-based care: Biomarkers are molecules in the tumor or blood that indicate normal or abnormal processes in participant's body and may indicate an underlying condition or disease. Various molecules, such as DNA (genes), proteins, or hormones, can serve as biomarkers since they all indicate something about participant's health. Biomarker testing can also help choose participant's treatment. Additionally, a tumor board will be conducted periodically to provide treatment recommendations to participant's treating physician. Participants will receive standard-of-care treatment if participant enroll in this study. Participant will not receive any experimental treatment. 2. Assistance with clinical trial enrollment. The study team will help participants enroll in a clinical trial appropriate for participant's condition. However, enrolling in a clinical trial is totally up to the participant. 3. Health literacy: The study team will provide information relevant to participant's diagnosis to enrich participant's understanding of participant's condition and treatment. Investigator will provide questionnaires to assess participant's understanding before and after participant's have been provided with educational/informational material appropriate for participant's diagnosis.

RECRUITING
Locally ablatIVe thErapy for oLigo-progressive gastrOintestiNal maliGnancies (LIVELONG)
Description

This is a phase 2 pragmatic study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary outcome measure is the time to treatment failure (defined as time to change in systemic failure or permanent discontinuation of therapy) following locally ablative therapy.

RECRUITING
Sacituzumab Govitecan in Combination With Capecitabine for Advanced Gastrointestinal Cancers After Progression on Standard Therapy
Description

This is a Phase I study to evaluate the safety and tolerability of sacituzumab govitecan in combination with capecitabine for advanced gastrointestinal cancers after progression on standard therapy, and to assess correlation of outcomes with the biomarker Trop-2.

ACTIVE_NOT_RECRUITING
Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers
Description

Prospective, multi-center, open label, non-randomized clinical trial to assess efficacy of \[18F\]FAPI-74 to detect FAP expressing cells in patients diagnosed with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer. The \[18F\]FAPI-74 PET scan will be acquired in patients with proven GI cancers after initial staging using institutional standard methods. The PET scan results will be compared to FAP immunohistochemistry (as the primary objective) and histopathology (as the secondary objective) of the biopsied or resected tissues.

COMPLETED
Intestinal Microbiome, Oral Microbiome, and Whole Blood Transcriptome Analyses in Gastrointestinal Malignancies
Description

The primary objective of this prospective observational study is to characterize the gut and oral microbiome as well as the whole blood transcriptome in gastrointestinal cancer patients and correlate these findings with cancer type, treatment efficacy and toxicity. Participants will be recruited from existing clinical sites only, no additional clinical sites are needed.

RECRUITING
Neratinib and Fam-Trastuzumab Deruxtecan in Advanced Gastro-esophageal Cancer Patients
Description

This is Phase 1 dose finding trial with potential dose expansion to evaluate the safety, toxicity, recommended phase 2 dose (RP2D), and maximum tolerated dose (MTD) of Neratinib plus TDxD using a standard 3+3 dose escalation design in patients with metastatic or unresectable gastro-esophageal cancer that are HER2-overexpressing (IHC 3+ or IHC2+/ISH+) and any other gastrointestinal cancer with HER2 expression with IHC3+. Patients must have progressed or been intolerant of at least one prior line of chemotherapy + HER2 directed therapy.

TERMINATED
A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Gastrointestinal Cancer (Master Protocol) (Pegathor Gastrointestinal 203)
Description

The study is a phase 2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of SAR444245 (THOR-707) combined with other anticancer therapies for the treatment of participants aged 18 years and older with advanced and metastatic gastrointestinal cancer. This study is structured as a master protocol for the investigation of SAR444245 with other anticancer therapies. Sub study 01 - Cohort A aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC). Sub study 02 - Cohort B1, B2 and B3 would focus on non MSI-H tumors with a large unmet need to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma (GC/GEJ), especially with low PD-L1 expression or after progression on prior PD1/PD-L1-based regimens. Sub study 03 - Cohort C aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in participants with advanced unresectable or metastatic HCC who relapsed on prior PD1/PD-L1-based regimens. Sub study 04 - Cohort D1 and D2 aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with either the anti-PD1 antibody pembrolizumab or with the anti-EGFR IgG1 antibody cetuximab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic colorectal cancer (mCRC).

ACTIVE_NOT_RECRUITING
Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer
Description

This is a Global Study of Neoadjuvant-Adjuvant Durvalumab or Placebo and FLOT Chemotherapy Followed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN).

COMPLETED
Oral Cryotherapy Plus Acupressure and Acupuncture Versus Oral Cryotherapy for Decreasing Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy in Patients With Gastrointestinal Cancer
Description

This phase II trial investigates how well oral cryotherapy plus acupressure and acupuncture compared with oral cryotherapy alone work in decreasing chemotherapy-induced peripheral neuropathy in patients with gastrointestinal cancer who are receiving oxaliplatin-based chemotherapy. Acupressure is the application of pressure or localized massage to specific sites on the body to control symptoms such as pain or nausea. Acupuncture is the technique of inserting thin needles through the skin at specific points on the body to control pain and other symptoms. Cryotherapy uses cold temperature such as oral ice chips to prevent abnormally increased pain sensation. Giving oral cryotherapy with acupressure and acupuncture may work better in decreasing chemotherapy-induced peripheral neuropathy from oxaliplatin-based chemotherapy in patients with gastrointestinal cancer compared to oral cryotherapy alone.

COMPLETED
Real-Time Monitoring of Chemotherapy Side-Effects in Patients With Gastrointestinal Cancers, RT-CAMSS Study
Description

This trial tests new methods and materials for the real-time chemotherapy-associated side effects monitoring support system (RT-CAMSS) in patients with gastrointestinal cancers undergoing chemotherapy. RT-CAMSS is a monitoring support system that provides patients with evidence-based information and side-effect management and coping skills, emotional support and validation, and proactive care via text messages and questionnaires as they undergo chemotherapy.

Conditions
Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8Clinical Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage 0 Gastric Cancer AJCC v8Clinical Stage I Esophageal Adenocarcinoma AJCC v8Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage I Gastric Cancer AJCC v8Clinical Stage II Esophageal Adenocarcinoma AJCC v8Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage II Gastric Cancer AJCC v8Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8Clinical Stage IIA Gastric Cancer AJCC v8Clinical Stage IIB Gastric Cancer AJCC v8Clinical Stage III Esophageal Adenocarcinoma AJCC v8Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage III Gastric Cancer AJCC v8Clinical Stage IV Esophageal Adenocarcinoma AJCC v8Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage IV Gastric Cancer AJCC v8Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage IVA Gastric Cancer AJCC v8Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8Clinical Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage IVB Gastric Cancer AJCC v8Pathologic Stage 0 Esophageal Adenocarcinoma AJCC v8Pathologic Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage 0 Gastric Cancer AJCC v8Pathologic Stage I Esophageal Adenocarcinoma AJCC v8Pathologic Stage I Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage I Gastric Cancer AJCC v8Pathologic Stage IA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IA Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IA Gastric Cancer AJCC v8Pathologic Stage IB Esophageal Adenocarcinoma AJCC v8Pathologic Stage IB Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IB Gastric Cancer AJCC v8Pathologic Stage IC Esophageal Adenocarcinoma AJCC v8Pathologic Stage II Esophageal Adenocarcinoma AJCC v8Pathologic Stage II Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage II Gastric Cancer AJCC v8Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIA Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IIA Gastric Cancer AJCC v8Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIB Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IIB Gastric Cancer AJCC v8Pathologic Stage III Esophageal Adenocarcinoma AJCC v8Pathologic Stage III Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage III Gastric Cancer AJCC v8Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IIIA Gastric Cancer AJCC v8Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IIIB Gastric Cancer AJCC v8Pathologic Stage IIIC Gastric Cancer AJCC v8Pathologic Stage IV Esophageal Adenocarcinoma AJCC v8Pathologic Stage IV Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IV Gastric Cancer AJCC v8Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8Stage 0 Colorectal Cancer AJCC v8Stage 0 Pancreatic Cancer AJCC v8Stage I Colorectal Cancer AJCC v8Stage I Pancreatic Cancer AJCC v8Stage IA Pancreatic Cancer AJCC v8Stage IB Pancreatic Cancer AJCC v8Stage II Colorectal Cancer AJCC v8Stage II Pancreatic Cancer AJCC v8Stage IIA Colorectal Cancer AJCC v8Stage IIA Pancreatic Cancer AJCC v8Stage IIB Colorectal Cancer AJCC v8Stage IIB Pancreatic Cancer AJCC v8Stage IIC Colorectal Cancer AJCC v8Stage III Colorectal Cancer AJCC v8Stage III Pancreatic Cancer AJCC v8Stage IIIA Colorectal Cancer AJCC v8Stage IIIB Colorectal Cancer AJCC v8Stage IIIC Colorectal Cancer AJCC v8Stage IV Colorectal Cancer AJCC v8Stage IV Pancreatic Cancer AJCC v8Stage IVA Colorectal Cancer AJCC v8Stage IVB Colorectal Cancer AJCC v8Stage IVC Colorectal Cancer AJCC v8
ACTIVE_NOT_RECRUITING
Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers
Description

This trial studies tucatinib to find out if it is safe when given with trastuzumab and other anti-cancer drugs (pembrolizumab, FOLFOX, and CAPOX). It will look at what side effects happen when participants take this combination of drugs. A side effect is anything the drug does other than treating cancer. It will also look at whether tucatinib works with these drugs to treat certain types of cancer. The participants in this trial have HER2-positive (HER2+) cancer in their gut, stomach, intestines, or gallbladder (gastrointestinal cancer).

ACTIVE_NOT_RECRUITING
A Study of Metastatic Gastrointestinal Cancers Treated With Tumor Infiltrating Lymphocytes in Which the Gene Encoding the Intracellular Immune Checkpoint CISH Is Inhibited Using CRISPR Genetic Engineering
Description

A clinical trial to assess the safety and efficacy of genetically-engineered, neoantigen-specific Tumor Infiltrating Lymphocytes (TIL) in which the intracellular immune checkpoint CISH has been inhibited using CRISPR gene editing for the treatment of Gastro-Intestinal (GI) Cancer.

RECRUITING
Radiation Therapy for the Treatment of Metastatic Gastrointestinal Cancers
Description

This phase II trial studies how well radiation therapy works for the treatment of gastrointestinal cancer that are spreading to other places in the body (metastatic). Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. This trial is being done to determine if giving radiation therapy to patients who are being treated with immunotherapy and whose cancers are progressing (getting worse) can slow or stop the growth of their cancers. It may also help researchers determine if giving radiation therapy to one tumor can stimulate the immune system to attack other tumors in the body that are not targeted by the radiation therapy.

Conditions
Stage IV Esophageal AdenocarcinomaStage IV Esophageal Squamous Cell CarcinomaStage IV Gastric CancerStage IV Adenocarcinoma of the Gastroesophageal JunctionStage IVA Esophageal AdenocarcinomaStage IVA Esophageal Squamous Cell CarcinomaStage IVA Gastric CancerStage IVA Adenocarcinoma of the Gastroesophageal JunctionStage IVB Esophageal AdenocarcinomaStage IVB Esophageal Squamous Cell CarcinomaStage IVB Gastric CancerStage IVB Gastroesophageal Junction AdenocarcinomaMetastatic Anal Canal CarcinomaMetastatic Colorectal CarcinomaMetastatic Esophageal CarcinomaMetastatic Gastric CarcinomaMetastatic Gastroesophageal Junction AdenocarcinomaMetastatic Hepatocellular CarcinomaMetastatic Malignant Digestive System NeoplasmMetastatic Small Intestinal CarcinomaPancreatobiliary CarcinomaPathologic Stage IV Gastric Cancer AJCC v8Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IV Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVA Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVB Esophageal Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVB Esophageal Squamous Cell Carcinoma AJCC V8Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8Stage IV Anal Cancer AJCC v8Stage IV Colorectal Cancer AJCC v8Stage IV Hepatocellular Carcinoma AJCC v8Stage IVA Colorectal Cancer AJCC v8Stage IVA Hepatocellular Carcinoma AJCC v8Stage IVB Colorectal Cancer AJCC v8Stage IVB Hepatocellular Carcinoma AJCC v8Stage IVC Colorectal Cancer AJCC v8
TERMINATED
Study to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors.
Description

A phase 1, open-label, dose escalation and expansion study of PF-07062119 in patients with selected advanced or metastatic gastrointestinal tumors

COMPLETED
Dasatinib for the Prevention of Oxaliplatin-Induced Neuropathy in Patients With Metastatic Gastrointestinal Cancer Receiving FOLFOX Chemotherapy With or Without Bevacizumab
Description

This phase Ib trial studies side effects and best dose of dasatinib in preventing oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancers who are receiving FOLFOX regimen with or without bevacizumab. Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin (FOLFOX regimen), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. However, the buildup of oxaliplatin in the cranial nerves can result in damage or the nerves. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Blocking these enzymes may reduce oxaliplatin-induced peripheral neuropathy.

ACTIVE_NOT_RECRUITING
A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer
Description

This is a multicenter, global, Phase 2, open-label, 2-part, first-line study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) plus standard first-line combination chemotherapy regimens for selected gastrointestinal (GI) cancers. Eligible patients include those with unresectable, locally advanced, recurrent or metastatic HER2-expressing gastroesophageal adenocarcinoma (GEA), biliary tract cancer (BTC), or colorectal cancer (CRC).

COMPLETED
Effects on Quality of Life With Zinc Supplementation in Patients With Gastrointestinal Cancer
Description

This randomized study examines how well zinc works in improving quality of life in patients with gastrointestinal cancer that cannot be removed by surgery who are receiving chemotherapy. Zinc may help to improve patient's quality of life by preventing zinc deficiency.

RECRUITING
Cabozantinib Plus Durvalumab with or Without Tremelimumab in Patients with Gastroesophageal Cancer and Other Gastrointestinal Malignancies
Description

The investigators propose to evaluate the safety of drug combinations in patients with advanced gastroesophageal cancer and other gastrointestinal (GI) malignancies. Finding effective novel therapies for patients with advanced gastric cancer and other GI malignancies is an area of great unmet need. The investigators believe that modulating the tumor microenvironment with biologic agents like cabozantinib will have synergistic effect when combined with checkpoint-based immunotherapeutics like durvalumab in this patient population. This is a phase I/II, open label, multi-cohort trial looking at safety, tolerability and efficacy endpoints.