RecruitingPhase 2NCT06592599

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

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)


Sponsor

Stanford University

Enrollment

24 participants

Start Date

Sep 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three cancer drugs — gemcitabine, docetaxel, and toripalimab (an immunotherapy) — as a first treatment before radiation for people with advanced nasopharyngeal cancer (a cancer in the back of the nose and throat) linked to the Epstein-Barr virus. **You may be eligible if...** - You have been diagnosed with locally advanced, EBV-positive nasopharyngeal cancer (specific stages T3-T4, or with lymph node involvement, but no distant spread) - You have never received treatment for this cancer before - You are 18 years or older - You are generally healthy enough to handle treatment (able to carry out light daily activities) - Your blood counts, liver, and kidney function are within acceptable ranges - You are willing to use birth control during treatment and for 4 months afterward **You may NOT be eligible if...** - You have already received chemotherapy or radiation for nasopharyngeal cancer - You have an active autoimmune disease or have had an organ transplant - You are pregnant or breastfeeding - You have had a heart attack or serious heart problem in the last 6 months - You have significant hearing loss that affects daily life - You have moderate or severe nerve damage in your hands or feet Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGToripalimab

Toripalimab will be administered 240 mg intravenously every three weeks in combination with the induction chemotherapy regimen for 3 cycles, and for 9 cycles as adjuvant treatment following radiation as specified in the overall sequential treatment plan.

RADIATIONConcurrent Chemoradiation and Adjuvant treatment following Chemoradiation

Radiation treatment will be initiated 3-6 weeks following day 1 of the last induction cycle using institutional standards of care and support as follows: Intensity modulated radiotherapy, 70 Gy in 33 fractions M-F once daily plus cisplatin 40 mg/m2 IV weekly for up to 7 doses. Following the completion of concurrent chemoradiation, capecitabine will be administered using institutional standards of care as follows: Capecitabine 650 mg/m2 PO BID x 12 months beginning 12 to 16 weeks following the end of radiation treatment. Dose reductions and discontinuance of capecitabine will be according to the standard of care applied at the treating institution. Adjuvant Toripalimab 240 mg IV q 21d x 9 maximum doses will be initiated concurrently with the initiation of adjuvant capecitabine, beginning 12-16 weeks following the end of radiation.


Locations(1)

Stanford University

Palo Alto, California, United States

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NCT06592599


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