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RECRUITING
NCT07328854
PHASE3

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

Sponsor: Ming-Yuan Chen

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

346

Start Date

2025-11-20

Completion Date

2032-06-30

Last Updated

2026-01-09

Healthy Volunteers

No

Interventions

DRUG

Cisplatin-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.)

DRUG

Full 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.

RADIATION

Reduced-dose radiotherapy to CTV2

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

RADIATION

Conventional-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