RecruitingPhase 3NCT04778956

Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma

Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma: a Prospecitve, Parallel, Multicenter, Phase III, Randomized Clinical Trial

Sponsor

Sun Yat-sen University

Enrollment

218 participants

Start Date

Mar 3, 2021

Study Type

INTERVENTIONAL

Conditions

Surgery Nasopharyngeal Carcinoma PD-1

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding toripalimab (an immunotherapy drug that helps the immune system attack cancer) before surgery improves outcomes in people with nasopharyngeal carcinoma (a head and neck cancer) that has come back after previous radiation treatment and is still surgically removable. **You may be eligible if...** - Your nasopharyngeal cancer has recurred (come back) at least 6 months after completing radiation therapy - The recurrence has been confirmed by biopsy - Your cancer is classified as resectable (can be surgically removed) — T1, T2, or T3 stage - You have not yet received surgery for this recurrence - You are in good enough physical condition for surgery **You may NOT be eligible if...** - Your cancer recurred less than 6 months after radiation - Your tumor cannot be surgically removed - Your cancer has spread to distant organs - You have significant heart, lung, liver, or kidney problems 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

Toripalimab: 240 mg, intravenous injection over 60 minutes (Q3W); Toripalimab should be completed for 2 cycles at 1-2 weeks before surgery, and continually applied since 1-2 weeks after surgery until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision, or 1 year.

PROCEDUREsalvage surgery

Endoscopic nasopharyngectomy is used for recurrent nasopharyngeal tumor and selective neck dissection for recurrent regional lymph node.