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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

490

Participants

Timeline

Start Date

August 1, 2023

Primary Completion Date

August 1, 2027

Study Completion Date

August 1, 2029

Conditions
Nasopharyngeal CarcinomaNasopharyngeal Cancer
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.

Trial Locations (18)

230041

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

233000

The First Affiliated Hospital of Bengbu Medical College, Bengbu

410000

Hunan Cancer Hospital, Changsha

430000

Renmin Hospital of Wuhan University, Wuhan

430071

Zhongnan Hospital of Wuhan University, Wuhan

510060

Sun Yat-Sen University Cancer Center, Guangzhou

Unknown

Cancer Hospital Chinese Academy of Medical Sciences, Beijing

Fujian Cancer Hospital, Fuzhou

Dongguan Peaple's Hospital, Dongguan

Zhongshan city Peaple's Hospital, Zhongshan

Cancer Hospital of Guangxi Medical University, Nanning

Cancer Hospital of Guizhou Medical University, Guiyang

Hubei Province Cancer Hosiptal, Wuhan

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

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

Xiangya Hospital Central South University, Changsha

Shandong Province Cancer Hospital, Jinan

Changhai Hospital of Shanghai, Shanghai

Sponsors
All Listed Sponsors
collaborator

Akeso Pharmaceuticals, Inc.

OTHER

lead

Sun Yat-sen University

OTHER