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RECRUITING
NCT06749899
PHASE3

QL1706 (PD-1/CTLA-4 Bi-specific Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma.

Sponsor: Sun Yat-Sen University Cancer Center

View on ClinicalTrials.gov

Summary

The trial aimed to compare QL1706 combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) versus IC+CCRT alone in High-risk Locoregionally-Advanced Nasopharyngeal Carcinoma (LANPC).

Official title: QL1706 (Iparomlimab and Tuvonralimab Injection,PD-1/ CTLA-4 Bi-specific Antibody) Combined With Chemoradiotherapy Versus Chemoradiotherapy Alone in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma:A Randomized, Controlled, Multicenter Phase III Clinical Study.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

580

Start Date

2025-05-04

Completion Date

2030-12-01

Last Updated

2025-05-22

Healthy Volunteers

No

Interventions

DRUG

QL1706

QL1706 5mg/kg will be given every 3 weeks for 3 cycles in induction chemotherapy and for 9 cycles in adjuvant chemotherapy, started on day 1 of induction chemotherapy and adjuvant chemotherapy, respectively.

DRUG

Gemcitabine

Gemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation.

DRUG

Cisplatin

Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation; Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation

RADIATION

Intensity-modulated radiotherapy

Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions.

Locations (19)

Fujian Cancer Hospital

Fuzhou, Fujian, China

Dongguan People's Hospital

Dongguan, Guangdong, China

First People's Hospital of Foshan

Foshan, Guangdong, China

Guangzhou Panyu Central Hospital

Guangzhou, Guangdong, China

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Zhongshan People's Hospital

Zhongshan, Guangdong, China

Cancer Hospital of Guangxi Medical University

Nanning, Guangxi, China

Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Hubei Province Cancer Hosiptal

Wuhan, Hubei, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

The Eye and ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Xiamen University

Fujian, Xiamen, China