Concurrent and Adjuvant PD1 Treatment Combined With Chemo-radiotherapy for High-risk Nasopharyngeal Carcinoma

PHASE3RecruitingINTERVENTIONAL
Enrollment

388

Participants

Timeline

Start Date

September 1, 2020

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2028

Conditions
Nasopharyngeal CancerChemotherapyRadiotherapyPD-1 Therapy
Interventions
DRUG

Camrelizumab plus chemo-radiotherapy

"1. Camrelizumab: 200 mg, intravenous injection over 60 minutes (Q3W); 2 cycles of camrelizumab are concurrently used during radiotherapy and camrelizumab are maintained for 1 year after the end of radiotherapy.~2. Gemcitabine plus cisplatin induction chemotherapy: gemcitabine is injected intravenously at the dose of 1000 mg/m2 on the 1st and 8th day (within 30 minutes) for 3 cycles; cisplatin is injected intravenously at the dose of 80 mg/m2 on the 1st day, for 3 cycles. 1 cycles per 3 weeks.~3. Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks.~4. IMRT: PTVnx#69.96Gy/33Fr/2.12Gy; PTVnd#69.96Gy/33Fr/2.12Gy; PTV1#59.4Gy/33Fr/1.8Gy; PTV2#54Gy/33Fr/1.64Gy"

DRUG

Chemo-radiotherapy alone

"1. Gemcitabine plus cisplatin induction chemotherapy: gemcitabine is injected intravenously at the dose of 1000 mg/m2 on the 1st and 8th day (within 30 minutes) for 3 cycles; cisplatin is injected intravenously at the dose of 80 mg/m2 on the 1st day, for 3 cycles. 1 cycles per 3 weeks.~2. Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks.~3. IMRT: PTVnx#69.96Gy/33Fr/2.12Gy; PTVnd#69.96Gy/33Fr/2.12Gy; PTV1#59.4Gy/33Fr/1.8Gy; PTV2#54Gy/33Fr/1.64Gy"

Trial Locations (6)

510060

RECRUITING

Sun Yat-sen University Cancer Center, Guangzhou

510095

NOT_YET_RECRUITING

Cancer Center of Guangzhou Medical University, Guangzhou

512025

NOT_YET_RECRUITING

Yuebei People's Hospital, Shaoguan

519000

RECRUITING

The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai

528403

RECRUITING

Zhongshan People's Hospital, Zhongshan

543002

NOT_YET_RECRUITING

Wuzhou Red Cross Hospital, Wuzhou

All Listed Sponsors
collaborator

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

OTHER

collaborator

Zhongshan People's Hospital, Guangdong, China

OTHER

collaborator

Yuebei People's Hospital

OTHER

collaborator

Wuzhou Red Cross Hospital

OTHER

collaborator

Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

lead

Sun Yat-sen University

OTHER

NCT04453826 - Concurrent and Adjuvant PD1 Treatment Combined With Chemo-radiotherapy for High-risk Nasopharyngeal Carcinoma | Biotech Hunter | Biotech Hunter