RecruitingPhase 2NCT07277764

Induction High-Low Dose Radiotherapy Plus Anti-PD-1 Followed by Definitive Radiotherapy in Recurrent Nasopharyngeal Carcinoma (Single-Arm Phase II)

Induction Therapy With High-Low Dose Radiotherapy Combined With Anti-PD-1 Monoclonal Antibody Followed by Definitive Radiotherapy in Recurrent Nasopharyngeal Carcinoma: A Single-Arm, Single-Center Phase II Trial


Sponsor

Jiangxi Provincial Cancer Hospital

Enrollment

23 participants

Start Date

Oct 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This single-arm, single-center phase II trial evaluates the safety and efficacy of a non-continuous radio-immunotherapy strategy for recurrent nasopharyngeal carcinoma (NPC) unsuitable for surgery. Induction consists of three fractions of low-dose radiotherapy (1.5 Gy ×3) plus high-dose boosts (5 Gy ×3 to tumor core with carotid/mucosal sparing) combined with anti-PD-1 (240 mg IV on Day 1 and Day 22). After a 21-28-day interval, definitive IMRT (2 Gy ×28, 5 days/week) is delivered without concurrent immunotherapy to minimize immune damage. Anti-PD-1 maintenance (240 mg IV Q3W) starts within 2 weeks after radiotherapy for up to 12 months or until progression/toxicity. The primary endpoint is ORR at 3 months post-radiotherapy; secondary endpoints include 3-year OS, 3-year PFS, safety (NCI-CTCAE v5.0), and quality of life (EORTC QLQ-C30). Key eligibility: histologically confirmed non-keratinizing NPC (WHO II/III), rT2-rT4, ECOG 0-1, adequate organ function.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a new radiation approach — combining high and low doses of radiation with an immunotherapy drug — as a treatment for nasopharyngeal carcinoma (a cancer at the back of the nose) that has come back after previous radiation therapy. **You may be eligible if...** - Your nasopharyngeal cancer has come back locally at least 1 year after completing your first course of radiation - The cancer has not spread to distant organs - You are not a candidate for surgery - Your cancer is at a specific stage (rT2-rT4 by AJCC 8th edition) - You are in good physical condition (ECOG 0–1) - Your organ function is adequate **You may NOT be eligible if...** - Your cancer has spread to distant sites (e.g., lungs, liver, bones) - There is active tissue death (necrosis) at the recurrence site - You have an active autoimmune disease - You have previously been treated with PD-1 or PD-L1 immunotherapy - You have uncontrolled infections (including active hepatitis B/C or HIV) - You are pregnant or breastfeeding 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

RADIATIONHigh-Low Dose Radiotherapy

Induction LD-RT 1.5 Gy ×3 (full lesion coverage) + HD boost 5 Gy ×3 (tumor core; carotid/mucosa sparing \<3 Gy/fx); followed by definitive IMRT 2 Gy ×28.


Locations(1)

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

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NCT07277764


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