RecruitingPhase 2NCT07332247

PD-1 Inhibitor Plus Chemotherapy Followed by Immediate Versus Selective Re-irradiation for Locally Advanced Recurrent NPC

An Open-Label, Randomized Controlled Phase II Clinical Trial of PD-1 Inhibitor Plus Chemotherapy Followed by Immediate Versus Selective Re-irradiation for Locally Advanced Recurrent Nasopharyngeal Carcinoma


Sponsor

Sun Yat-sen University

Enrollment

94 participants

Start Date

Feb 3, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II randomized trial evaluates PD-1 inhibitor plus chemotherapy followed by immediate versus selective re-irradiation in locally advanced recurrent nasopharyngeal carcinoma. The study aims to determine whether sequential radiotherapy provides additional survival benefit beyond systemic immunochemotherapy.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches for treating locally recurrent nasopharyngeal cancer (cancer at the back of the nose/throat that has come back): giving re-irradiation immediately after chemotherapy plus immunotherapy, versus giving re-irradiation only when disease progresses further. The goal is to find the best timing for re-treatment. **You may be eligible if...** - You are between 18 and 70 years old - Your nasopharyngeal cancer has come back locally more than one year after your original treatment - Your cancer responded (fully or partially) to 4–6 cycles of chemotherapy plus a PD-1 inhibitor - You have not received any treatment for the recurrence before enrolling - Your blood counts and organ function meet the required thresholds **You may NOT be eligible if...** - Surgery is an option for you - You have already received treatment for the recurrent cancer - You have conditions that would prevent you from receiving immunotherapy, chemotherapy, or radiation - Your performance level or organ function does not meet study requirements 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

RADIATIONSelective re-irradiation

PD-1 inhibitor maintenance + Selective re-irradiation PD-1 inhibitor maintenance therapy:Toripalimab 240 mg IV on day 1 every 3 weeks, or Tislelizumab 200 mg IV on day 1 every 3 weeks, or Camrelizumab 200 mg IV on day 1 every 3 weeks, continued until disease progression (per RECIST v1.1; if progression occurs in the nasopharynx or neck, re-irradiation will be administered and PD-1 maintenance will continue until subsequent progression), unacceptable toxicity, patient withdrawal, or a maximum treatment duration of 2 years.

RADIATIONImmediate re-irradiation

Immediate re-irradiation + PD-1 inhibitor Maintenance: Re-irradiation will be administered Immediately. PD-1 inhibitor maintenance therapy: Toripalimab 240 mg IV on day 1 every 3 weeks, or Tislelizumab 200 mg IV on day 1 every 3 weeks, or Camrelizumab 200 mg IV on day 1 every 3 weeks, continued until disease progression (per RECIST v1.1), unacceptable toxicity, patient withdrawal, or a maximum treatment duration of 2 years.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT07332247


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