RecruitingPhase 3NCT05340491

Chemoradiotherapy Plus Anti-PD1 in Recurrent NPC: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial

Chemoradiotherapy Combined With Programmed Death 1 Antibody in Recurrent Nasopharyngeal Carcinoma: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial


Sponsor

Sun Yat-sen University

Enrollment

212 participants

Start Date

Apr 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, open-label, randomized, controlled, phase III trial. The purpose of this trial is to evaluate the efficacy and toxicity of anti-PD-1 antibody combined with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an immunotherapy drug (anti-PD1) to standard chemoradiotherapy can improve outcomes for patients with nasopharyngeal carcinoma (NPC — a cancer of the back of the throat) that has come back locally after previous treatment. **You may be eligible if...** - Your NPC came back in the same local/regional area, at least 1 year after your original treatment - Surgery is not an option for you - Your recurrent cancer is stage rII–IVa - You have not received any treatment for this recurrence yet - Your blood counts and organ function (liver, kidneys, bone marrow) meet the required levels - You are generally active and functional (ECOG 0–1) **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have received any prior treatment for this recurrence - You have contraindications to immunotherapy or chemoradiotherapy 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

240mg, D1, every 3 weeks per cycle, three cycles with chemotherapy and eight cycles after IMRT

DRUGChemotherapy

Gemcitabine: 1.0g/m2, D1 and D8, Cisplatin 80mg/m2, D1, every 3 weeks per cycle, total three cycles

RADIATIONIntensity modulated radiotherapy

total 60-66Gy, 1.8-2.0Gy/f/day


Locations(12)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Peking University Third Hospital

Beijing, China

Sichuan Cancer Hospital

Chengdu, China

Fujian Province Cancer Hospital

Fuzhou, China

Guizhou Cancer Hospital

Guiyang, China

Zhejiang Cancer Hospital

Hangzhou, China

Jiangxi Cancer Hospital

Nanchang, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, China

Fudan University Shanghai Cancer Center

Shanghai, China

Zhongnan Hospital of Wuhan University

Wuhan, China

Xijing Hospital

Xi'an, China

The First Affiliated Hospital of Xiamen University

Xiamen, China

View Full Details on ClinicalTrials.gov

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NCT05340491


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