RecruitingPhase 3NCT04376866

Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma

Toripalimab in Combination With Concurrent Chemoradiotherapy for Local-regional Recurrent Nasopharyngeal Carcinoma: a Phase 3, Multicentre, Randomised Controlled Trial


Sponsor

Cancer Hospital of Guangxi Medical University

Enrollment

204 participants

Start Date

Jun 28, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase 3, multicentre, randomised controlled trial to study the effectiveness and toxicity of PD-1 antibody Toripalimab combined with concurrent cisplatin chemoradiotherapy versus cisplatin concurrent chemoradiotherapy alone in treating patients with locoregionally recurrent nasopharyngeal carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests toripalimab, an immunotherapy drug that helps the immune system fight cancer, for people with nasopharyngeal carcinoma (a type of throat cancer at the back of the nose) that has come back after previous treatment. The goal is to determine whether this drug combined with re-irradiation can improve outcomes. **You may be eligible if...** - You are between 18 and 65 years old - You have a confirmed recurrence of nasopharyngeal carcinoma (either confirmed by biopsy or shown on at least two imaging scans) - Your cancer is at a locally recurrent stage (not yet widely spread) - Your blood counts and organ function (liver, kidneys) are within acceptable ranges - Your overall health status is good (ECOG 0-1) **You may NOT be eligible if...** - You are over 65 or under 18 - You have active hepatitis B with high viral load, or positive hepatitis C antibody - You have an active autoimmune disease requiring systemic treatment - You have a history of lung disease (interstitial lung disease) - You have HIV - You are pregnant or breastfeeding - You have had another cancer in the past 5 years (except certain thyroid, skin, or in-situ cancers) - You have severe uncontrolled medical conditions or infections 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

anti-PD-1 antibody


Locations(1)

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

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NCT04376866


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