RecruitingPhase 3NCT06177301

Tislelizumab Plus GX Versus Tislelizumab Plus GP in the Treatment of R/M NPC

A Phase III Clinical Study of Tislelizumab Combined With GX Regimen Versus Tislelizumab Combined With GP Regimen in the First-line Treatment of Recurrence or Metastasis (R/M) Nasopharyngeal Carcinoma (NPC)


Sponsor

Fudan University

Enrollment

266 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The study is being conducted to evaluate the safety and efficacy of tislelizumab combined with GX regimen versus tislelizumab combined with GP regimen in the first-line treatment of nasopharyngeal carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two immunotherapy-plus-chemotherapy combinations for people with recurrent or metastatic nasopharyngeal carcinoma (a type of head and neck cancer): tislelizumab plus gemcitabine/capecitabine (GX regimen) versus tislelizumab plus gemcitabine/cisplatin (GP regimen), to see which works better. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed recurrent or metastatic nasopharyngeal carcinoma - You have not had prior systemic treatment for your recurrent or metastatic disease (prior adjuvant or concurrent chemoradiotherapy is allowed if relapse occurred at least 6 months after finishing chemotherapy) - You have good performance status (ECOG 0-1) and at least one measurable lesion on imaging - Your blood counts and organ function meet the required levels **You may NOT be eligible if...** - You have already received systemic chemotherapy for metastatic/recurrent NPC - You have serious autoimmune disease or are on immune-suppressing drugs - You have uncontrolled infections or significant other medical conditions 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

DRUGTislelizumab combined with GX

Tislelizumab:200mg vgtt,q3w;treatment until disease progression, patients withdrawal of informed, or intolerable toxicity. Gemcitabine:1000mg/m2, vgtt, d1,8, q3w, repeat 4-6 cycles. Capecitabine: 1000mg/m2, bid,po, d1-14, q3; treatment until disease progression, patients withdrawal of informed, or intolerable toxicity.

DRUGTislelizumab combined with GP

Tislelizumab: 200mg vgtt,q3w;treatment until disease progression, patients withdrawal of informed, or intolerable toxicity. Gemcitabine: 1000mg/m2, vgtt, d1,8, q3w, repeat 4-6 cycles; Cisplatin: 80mg/m2, ivgtt, d1 (high-dose cisplatin antiemetic and hydration regimen), q3w,repeat 4 \~ 6 cycles.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06177301


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