RECRUITING

Endoscopic Ultrasound Radiofrequency Ablation and Immunotherapy Pembrolizumab for Locally Advanced Unresectable and Metastatic Pancreatic Duct Adenocarcinoma

Conditions

Pancreatic Ductal Adenocarcinoma metastatic cancer chemotherapy systemic immunotherapy pembrolizumab neoplasms Endoscopic Ultrasound Radiofrequency ablation (EUS-RFA)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to perform a pilot phase II trial to evaluate the safety and efficacy of combined EUS-RFA, chemotherapy, and systemic immunotherapy (pembrolizumab) for the treatment of locally advanced unresectable and metastatic Pancreatic ductal adenocarcinoma (mPDAC).

Official Title

Endoscopic Ultrasound Radiofrequency Ablation and Immunotherapy Pembrolizumab for Locally Advanced Unresectable and Metastatic Pancreatic Duct Adenocarcinoma; a Phase II Trial PANcreas CAncer RaDIofrequeNcy AbLation

Quick Facts

Study Start:2025-03-26

Study Completion:2030-01-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06831136

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Is willing and able to comply with the protocol for the duration of the study,including undergoing treatment and scheduled visits and examinations, including follow-up * Biopsy-proven locally advanced unresectable or metastatic PDAC 1. Patients who have undergone prior resection will be excluded unless there is recurrent pancreatic tumor that is amenable to EUS-RFA. 2. If biliary metal stent is placed, during procedure of EUS-RFA, indwelling biliary metal stent will be removed during initial EUS-RFA and then replaced with plastic stent. * Mental capacity to provide informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol * Eastern Cooperative Oncology Group (ECOG) Performance status 0-2 * At least one measurable metastatic lesion on axial imaging per Response Evaluation Criteria in Solid Tumors (RECIST) v1. * No prior systemic therapy, including chemotherapy or chemoradiation is permitted with the following exceptions: 1. Prior adjuvant therapy (including chemotherapy and/or radiotherapy) for pancreatic adenocarcinoma is permitted if neoadjuvant or adjuvant therapy was completed at least 3 months prior to study enrollment. Prior adjuvant therapy may include mFFX, NALIRIFOX, or GA. 2. If started on first-line treatment for mPDAC elsewhere (i.e., not at our study site), eligible participants can have undergone 3 months of chemotherapy with stable disease before study entry. Note: Imaging done outside the site will need to be reviewed for a 2nd opinion to confirm stable disease. * Absolute neutrophil count (ANC) ≥1 x 109/L * Platelet count ≥75 x 109/L * Total serum bilirubin \<2× upper limit of normal (ULN) unless secondary to Gilbert's Syndrome * Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤3× ULN, or ≤5× ULN in cases of documented liver involvement * Serum creatinine clearance must be ≥30 mL/minute either measured or calculated using a standard Cockcroft and Gault formula * Prior surgery that required general anesthesia or other major surgery as defined by the Investigator must be completed at least 4 weeks before immunotherapy.	* No telephone number and permanent street address * Pregnant or breastfeeding patients; or is a male or female patient of reproductive potential who is not willing to employ effective birth control from time of screening to 90 days after the last dose * Inmates or prisoners * Unable to provide informed consent * Resectable, borderline resectable PDAC. * Known history of central nervous system (CNS) metastases * Has a history of another primary malignancy. Patients having the following are still eligible: 1. No active stage 4 cancer 2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease 3. Adequately treated carcinoma in situ without evidence of disease * Known low or absent dihydropyrimidine dehydrogenase (DPD) activity * Use of strong inhibitors or inducers of Cytochrome P450 3A (CYP3A), CYP2C8 and UGT1A1 * History or evidence of clinically significant or uncontrolled cardiovascular, CNS,and/or other systemic disease that in the investigator's opinion would preclude participation in the study or compromise the patient's ability to give informed consent * History of HIV or active tuberculosis (TB) (PPD response without active TB is allowed) * Underlying medical conditions that, in the Investigator's opinion, will make the administration of pembrolizumab hazardous (e.g., interstitial lung disease, active infections requiring antibiotics, recent hospitalization with unresolved symptoms) * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial * Any active autoimmune disease or a documented history of autoimmune disease or history of a syndrome that required systemic steroids or immunosuppressive medications, except for vitiligo or resolved childhood asthma/atopy 1. Participants with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study. 2. Physiologic doses of corticosteroids (≤10 mg/day of prednisone or its equivalent) or short pulses of corticosteroids (≤3 days) may be permitted. 3. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement 4. Patients having any chronic skin condition that does not require systemic therapy 5. Patients without active disease in the last 5 years (allowed only after consultation with the study physician) 6. Patients with celiac disease controlled by diet alone * Is currently using or previously used immunosuppressive medication within 14 days before the first dose of pembrolizumab. The following medications are exceptions to this criterion: 1. intranasal, inhaled, topical steroid, or local steroid injections (e.g., intra articular injection) 2. Systemic corticosteroids at physiologic doses not to exceed 10mg/day of prednisone or its equivalent 3. steroids as premedication for hypersensitivity reactions (e.g., computer tomography \[CT\] scan premedication)

Inclusion Criteria

Exclusion Criteria

* Is willing and able to comply with the protocol for the duration of the study,including undergoing treatment and scheduled visits and examinations, including follow-up
* Biopsy-proven locally advanced unresectable or metastatic PDAC
1. Patients who have undergone prior resection will be excluded unless there is recurrent pancreatic tumor that is amenable to EUS-RFA.
2. If biliary metal stent is placed, during procedure of EUS-RFA, indwelling biliary metal stent will be removed during initial EUS-RFA and then replaced with plastic stent.
* Mental capacity to provide informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
* Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
* At least one measurable metastatic lesion on axial imaging per Response Evaluation Criteria in Solid Tumors (RECIST) v1.
* No prior systemic therapy, including chemotherapy or chemoradiation is permitted with the following exceptions:
1. Prior adjuvant therapy (including chemotherapy and/or radiotherapy) for pancreatic adenocarcinoma is permitted if neoadjuvant or adjuvant therapy was completed at least 3 months prior to study enrollment. Prior adjuvant therapy may include mFFX, NALIRIFOX, or GA.
2. If started on first-line treatment for mPDAC elsewhere (i.e., not at our study site), eligible participants can have undergone 3 months of chemotherapy with stable disease before study entry. Note: Imaging done outside the site will need to be reviewed for a 2nd opinion to confirm stable disease.
* Absolute neutrophil count (ANC) ≥1 x 109/L
* Platelet count ≥75 x 109/L
* Total serum bilirubin \<2× upper limit of normal (ULN) unless secondary to Gilbert's Syndrome
* Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤3× ULN, or ≤5× ULN in cases of documented liver involvement
* Serum creatinine clearance must be ≥30 mL/minute either measured or calculated using a standard Cockcroft and Gault formula
* Prior surgery that required general anesthesia or other major surgery as defined by the Investigator must be completed at least 4 weeks before immunotherapy.

* No telephone number and permanent street address
* Pregnant or breastfeeding patients; or is a male or female patient of reproductive potential who is not willing to employ effective birth control from time of screening to 90 days after the last dose
* Inmates or prisoners
* Unable to provide informed consent
* Resectable, borderline resectable PDAC.
* Known history of central nervous system (CNS) metastases
* Has a history of another primary malignancy. Patients having the following are still eligible:
1. No active stage 4 cancer
2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
3. Adequately treated carcinoma in situ without evidence of disease
* Known low or absent dihydropyrimidine dehydrogenase (DPD) activity
* Use of strong inhibitors or inducers of Cytochrome P450 3A (CYP3A), CYP2C8 and UGT1A1
* History or evidence of clinically significant or uncontrolled cardiovascular, CNS,and/or other systemic disease that in the investigator's opinion would preclude participation in the study or compromise the patient's ability to give informed consent
* History of HIV or active tuberculosis (TB) (PPD response without active TB is allowed)
* Underlying medical conditions that, in the Investigator's opinion, will make the administration of pembrolizumab hazardous (e.g., interstitial lung disease, active infections requiring antibiotics, recent hospitalization with unresolved symptoms)
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
* Any active autoimmune disease or a documented history of autoimmune disease or history of a syndrome that required systemic steroids or immunosuppressive medications, except for vitiligo or resolved childhood asthma/atopy
1. Participants with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study.
2. Physiologic doses of corticosteroids (≤10 mg/day of prednisone or its equivalent) or short pulses of corticosteroids (≤3 days) may be permitted.
3. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
4. Patients having any chronic skin condition that does not require systemic therapy
5. Patients without active disease in the last 5 years (allowed only after consultation with the study physician)
6. Patients with celiac disease controlled by diet alone
* Is currently using or previously used immunosuppressive medication within 14 days before the first dose of pembrolizumab. The following medications are exceptions to this criterion:
1. intranasal, inhaled, topical steroid, or local steroid injections (e.g., intra articular injection)
2. Systemic corticosteroids at physiologic doses not to exceed 10mg/day of prednisone or its equivalent
3. steroids as premedication for hypersensitivity reactions (e.g., computer tomography \[CT\] scan premedication)

Contacts and Locations

Study Contact

Putao Cen, MD

CONTACT

(832) 325-7705

pancreasresearch@uth.tmc.edu

Ayodeji Adeniji

CONTACT

(713) 500-5377

Ayodeji.Adeniji@uth.tmc.edu

Principal Investigator

Putao Cen

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Study Locations (Sites)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

Putao Cen, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-26

Study Completion Date2030-01-20

Study Record Updates

Study Start Date2025-03-26

Study Completion Date2030-01-20

Terms related to this study

Keywords Provided by Researchers

metastatic cancer
chemotherapy
systemic immunotherapy
pembrolizumab
neoplasms
Endoscopic Ultrasound Radiofrequency ablation (EUS-RFA)

Additional Relevant MeSH Terms

Pancreatic Ductal Adenocarcinoma