RecruitingPhase 3NCT03907826

PD-1 Antibody Combined With Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients

PD-1 Antibody Combined With Chemoradiotheapy vs. Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients: a Multicenter, Randomised Controlled, Phase III Clinical Trial


Sponsor

Sun Yat-sen University

Enrollment

212 participants

Start Date

Mar 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody 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 combining immunotherapy (a PD-1 blocking drug) with chemotherapy and radiation can improve outcomes for people whose nasopharyngeal cancer (a cancer at the back of the nose and throat) has returned locally after prior treatment. **You may be eligible if...** - Your nasopharyngeal cancer has come back locally at least 1 year after completing prior treatment - You are not a candidate for surgery - Your recurrent cancer is at a locally advanced stage (rII through rIVa) - You are in good general health (ECOG 0-1), have not yet received treatment for the recurrence, and have adequate blood and organ function **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have already received treatment targeting the recurrence - You have contraindications to immunotherapy or radiation 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

DRUGPD-1 blocking antibody

Toripalimab 240mg, D1, every 3 weeks per cycle

DRUGGP

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

RADIATIONIMRT

IMRT 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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NCT03907826


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