RECRUITING

Gemcitabine + Docetaxel + Toripalimab Induction in Epstein-Barr Virus (EBV) Associated Nasopharyngeal Carcinoma(NPC)

Conditions

Nasopharyngeal Carcinoma gemcitabine docetaxel toripalimab

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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 the research is to test the safety and efficacy of the investigational drug in human subjects with cancer.

Official Title

A Safety, Feasibility and Efficacy Study of Gemcitabine Plus Docetaxel Plus Toripalimab (GDT) Induction as Part of a Curative Sequential Chemoradiation for Patients With Locoregional EBV Associated Nasopharyngeal Carcinoma (NPC)

Quick Facts

Study Start:2024-09-02

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06592599

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
1. Eligible disease(s) / stage(s): Locoregionally advanced EBV positive NPC (T3-4, any N OR any T, N1-3. No M1) per AJCC v 8 2. Prior therapy: None for NPC permitted 3. Life expectancy: 3 months at least 4. Contraception requirements: Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control during treatment with toripalimab and for 4 months after the last dose. 5. ECOG Performance Status of 0,1, or 2 6. Age: At least 18 years old. 7. Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 8. Platelets ≥ 100,000 cells/mm3; 9. Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.); 10. Total bilirubin ≤ 1.5 x institutional ULN; 11. AST and ALT ≤ 1.5 x institutional ULN; 12. Serum creatinine ≤ 1.5 mg/dl or calculated or measured creatinine clearance (CC) ≥ 50 ml/min 13. Negative serum pregnancy test within 14 days prior to day 1 of treatment for women of childbearing potential 14. Ability to understand and the willingness to personally sign the written IRB approved informed consent document.	1. Prior systemic anticancer treatment for NPC 2. Prior radiation to head and neck region or regions necessitating overlapping fields 3. Concurrent use of any anti- cancer treatment, standard, alternative or investigational. 4. History of allergic reactions to any agents in this study 5. Autoimmune disease or organ transplant which in the judgment of the PI would increase the risk of immune checkpoint inhibition. 6. Pregnant or breastfeeding 7. Severe, active co-morbidity, defined as follows: * Major medical or psychiatric illness, which in the investigator's opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy; * Unstable angina and/or uncontrolled congestive heart failure within past 6 months; * Myocardial infarction within the last 6 months; * Current acute bacterial or fungal infection requiring intravenous antibiotics; note that patients receiving IV antibiotics or currently on oral antibiotics whose infection is assessed to be adequately treated or controlled are eligible. * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to day 1 of treatment; 8. Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive 9. Patients with hearing loss assessed to be primarily sensorineural in nature, requiring a hearing aid, or intervention (i.e. interfering in a clinically significant way with activities of daily living); a conductive hearing loss that is tumor-related is allowed 10. ≥ grade 2 peripheral sensory neuropathy

Inclusion Criteria

Exclusion Criteria

1. Eligible disease(s) / stage(s): Locoregionally advanced EBV positive NPC (T3-4, any N OR any T, N1-3. No M1) per AJCC v 8
2. Prior therapy: None for NPC permitted
3. Life expectancy: 3 months at least
4. Contraception requirements: Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control during treatment with toripalimab and for 4 months after the last dose.
5. ECOG Performance Status of 0,1, or 2
6. Age: At least 18 years old.
7. Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
8. Platelets ≥ 100,000 cells/mm3;
9. Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.);
10. Total bilirubin ≤ 1.5 x institutional ULN;
11. AST and ALT ≤ 1.5 x institutional ULN;
12. Serum creatinine ≤ 1.5 mg/dl or calculated or measured creatinine clearance (CC) ≥ 50 ml/min
13. Negative serum pregnancy test within 14 days prior to day 1 of treatment for women of childbearing potential
14. Ability to understand and the willingness to personally sign the written IRB approved informed consent document.

1. Prior systemic anticancer treatment for NPC
2. Prior radiation to head and neck region or regions necessitating overlapping fields
3. Concurrent use of any anti- cancer treatment, standard, alternative or investigational.
4. History of allergic reactions to any agents in this study
5. Autoimmune disease or organ transplant which in the judgment of the PI would increase the risk of immune checkpoint inhibition.
6. Pregnant or breastfeeding
7. Severe, active co-morbidity, defined as follows:
* Major medical or psychiatric illness, which in the investigator's opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy;
* Unstable angina and/or uncontrolled congestive heart failure within past 6 months;
* Myocardial infarction within the last 6 months;
* Current acute bacterial or fungal infection requiring intravenous antibiotics; note that patients receiving IV antibiotics or currently on oral antibiotics whose infection is assessed to be adequately treated or controlled are eligible.
* Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to day 1 of treatment;
8. Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive
9. Patients with hearing loss assessed to be primarily sensorineural in nature, requiring a hearing aid, or intervention (i.e. interfering in a clinically significant way with activities of daily living); a conductive hearing loss that is tumor-related is allowed
10. ≥ grade 2 peripheral sensory neuropathy

Contacts and Locations

Study Contact

Elizabeth Winters

CONTACT

(650) 723-6372

ewinters@stanford.edu

Principal Investigator

A. Dimitrios Colevas, MD

PRINCIPAL_INVESTIGATOR

Stanford University

Study Locations (Sites)

Stanford University

Palo Alto, California, 94304

United States

Collaborators and Investigators

Sponsor: Stanford University

A. Dimitrios Colevas, MD, PRINCIPAL_INVESTIGATOR, Stanford University

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 Date2024-09-02

Study Completion Date2027-12

Study Record Updates

Study Start Date2024-09-02

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

gemcitabine
docetaxel
toripalimab

Additional Relevant MeSH Terms

Nasopharyngeal Carcinoma