RecruitingPhase 3NCT07328854

40.2Gy Versus 49.2Gy Radiotherapy in Low-Risk Target Volume for Chemosensitive Stage II Nasopharyngeal Carcinoma

40.2Gy Versus 49.2Gy Radiotherapy in Low-Risk Target Volume for Chemosensitive Stage II Nasopharyngeal Carcinoma Under Full-Course Immunotherapy: a Multicentre, Randomised, Phase 3 Trial


Sponsor

Ming-Yuan Chen

Enrollment

346 participants

Start Date

Nov 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to explore the efficacy and adverse events of reduced-dose radiotherapy (40.2Gy) versus conventional-dose radiotherapy (49.2Gy) to low-risk target volume for chemosensitive intermediate-stage nasopharyngeal carcinoma patients.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two radiation doses for the low-risk target area in stage II nasopharyngeal cancer patients who have responded very well to initial chemotherapy and immunotherapy. Researchers hope to find out if a lower radiation dose gives equally good outcomes with fewer side effects. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with stage II nasopharyngeal cancer confirmed by biopsy - After 3 cycles of induction chemotherapy (including immunotherapy), your tumor has responded (complete or partial response confirmed by imaging) - Your Epstein-Barr virus (EBV) DNA levels have dropped to undetectable - Your KPS health performance score is 70 or above - Your blood counts and liver and kidney function are within normal ranges **You may NOT be eligible if...** - Your cancer has returned or spread to distant organs - You are pregnant or breastfeeding - You have not responded adequately to initial chemotherapy - You have a history of another malignancy or other conditions that may interfere with treatment 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

DRUGCisplatin-based induction chemotherapy

Gemcitabine + cisplatin: Gemcitabine, 1,000 mg/m², Q3W, d1+d8, IV drip; cisplatin, 80 mg/m², Q3W, d1-3, IV drip. A total of 3 cycles. (Note: Gemcitabine can be replaced by docetaxel, albumin-bound paclitaxel, paclitaxel, etc.)

DRUGFull course of PD-1 monoclonal antibody

Tislelizumab 200 mg , once every 3 weeks (Q3W), intravenous infusion (iv). A total of 12 courses of treatment will be administered, including 3 courses during the induction chemotherapy phase, 3 courses during the radiotherapy phase, and 6 courses during the post-radiotherapy maintenance phase. Administration will start on Day 1 of induction chemotherapy and continue after the end of radiotherapy until the occurrence of intolerable toxicities, disease progression, withdrawal of consent, determination by the investigator that the patient needs to withdraw from treatment, or the completion of 12 courses, whichever comes first.

RADIATIONReduced-dose radiotherapy to CTV2

GTV, 63.6Gy/30Fr/2.12Gy; CTV1, 54Gy/30Fr/1.8Gy; CTV2, 40.2Gy/30F/1.34Gy

RADIATIONConventional-dose radiotherapy to CTV2

GTV, 63.6Gy/30Fr/2.12Gy; CTV1, 54Gy/30Fr/1.8Gy; CTV2, 49.2Gy/30Fr/1.64Gy


Locations(15)

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Sun Yat-sen University cancer center

Guangzhou, Guangdong, China

the Affiliated Cancer Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China

Zhongshan City People's Hospital

Zhongshan, Guangdong, China

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, China

Central South University Cancer Hospital,

Changsha, Hunan, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

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