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ACTIVE NOT RECRUITING
NCT05587374
PHASE3

Cadonilimab (PD-1/CTLA-4 Bispecific Blockade) and Chemoradiotherapy in Nasopharyngeal Carcinoma (GEMSTONE)

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

The trial aimed to compare cadonilimab combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) versus IC+CCRT alone in high-risk locoregionally-advanced nasopharyngeal carcinoma (LANPC).

Official title: Cadonilimab as Induction-adjuvant PD-1/CTLA-4 Bispecific Blockade Combined With Induction Chenotherapy and Concurrent Chemoradiotherapy in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma: a Multicenter, Randomized, Controlled, Multicenter, Phase 3 Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

490

Start Date

2023-08-01

Completion Date

2029-08-01

Last Updated

2025-01-23

Healthy Volunteers

No

Interventions

DRUG

Cadonilimab

Cadonilimab 10mg/kg will be given every 3 weeks for 3 cycles in induction chemotherapy and for 14 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 (18)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Dongguan Peaple's Hospital

Dongguan, Guangdong, China

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Zhongshan city Peaple's Hospital

Zhongshan, Guangdong, China

Cancer Hospital of Guangxi Medical University

Nanning, Guangxi, China

Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Hubei Province Cancer Hosiptal

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 Central South University

Changsha, Hunan, China

Shandong Province Cancer Hospital

Jinan, Shandong, China

Changhai Hospital of Shanghai

Shanghai, Shanghai Municipality, China