RecruitingPhase 3NCT04453813

Toripalimab Plus Concurrent Chemo-radiotherapy for Unresectable Locally Recurrent Nasopharyngeal Carcinoma

A Multicenter Randomized Clinical Phase 3 Trial of Toripalimab Plus Concurrent Chemo-radiotherapy vs Concurrent Chemo-radiotherapy Alone for Unresectable Locally Recurrent Nasopharyngeal Carcinoma


Sponsor

Sun Yat-sen University

Enrollment

226 participants

Start Date

Jul 3, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that concurrent and adjuvant PD-1 treatment added to concurrent chemo-radiotherapy could further decrease the rate of disease progression and improve the survival outcome of patients with unresectable locally recurrent nasopharyngeal carcinoma compared with those treated with concurrent chemo-radiotherapy alone.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding toripalimab — an immunotherapy drug that helps the immune system attack cancer — to standard chemotherapy and radiation can improve outcomes for patients whose nasopharyngeal cancer (cancer at the back of the nose/throat) has come back and cannot be removed with surgery. **You may be eligible if:** - You have confirmed recurring nasopharyngeal cancer (confirmed by biopsy) - Your cancer came back more than 12 months after finishing your first round of radiation - Your cancer has not spread to distant organs - Your general health score (Karnofsky) is 70 or above - Your blood, liver, and kidney test results are within acceptable ranges **You may NOT be eligible if:** - Your cancer could potentially be surgically removed - You have severe radiation-related complications such as tissue death in the throat or brain injury from prior radiation - You have an active autoimmune disease - You have another active cancer - You have a known allergy to the study medications - You have a history of significant psychiatric illness or substance abuse 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 plus concurrent chemo-radiotherapy

1. Toripalimab: 240 mg, intravenous injection over 60 minutes (Q3W); 2 cycles of toripalimab are concurrently used during radiotherapy and other 9 cycles of toripalimab are used after the end of radiotherapy. (A total of 11 cycles). 2. Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks. 3. IMRT: PTVnx#60.0Gy/27Fr/2.22Gy; PTVnd# 60-64Gy/27Fr/2.22-2.37Gy; PTV1#54Gy/27Fr/2.00Gy

DRUGConcurrent chemo-radiotherapy

1. Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks. 2. IMRT: PTVnx#60.0Gy/27Fr/2.22Gy; PTVnd# 60-64Gy/27Fr/2.22-2.37Gy; PTV1#54Gy/27Fr/2.00Gy


Locations(6)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Cancer Center of Guangzhou Medical University

Guangzhou, Guangdong, China

Yuebei People's Hospital

Shaoguan, Guangdong, China

Zhongshan People's Hospital

Zhongshan, Guangdong, China

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, China

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NCT04453813


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