Concurrent and Adjuvant Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation in Nasopharyngeal Carcinoma

NARecruitingINTERVENTIONAL
Enrollment

288

Participants

Timeline

Start Date

December 1, 2022

Primary Completion Date

November 30, 2024

Study Completion Date

November 30, 2027

Conditions
Nasopharyngeal Carcinoma by AJCC V8 Stage
Interventions
DRUG

Nimotuzumab

"Drug: Nimotuzumab Experimental: Nimotuzumab arm Induction chemotherapy:Nimotuzumab 200mg will be given weekly for 6 cycles, started on day 1 of induction chemotherapy.~Concurrent chemotherapy: Nimotuzumab 200mg/week in concurrent with IMRT. Adjuvant therapy: Nimotuzumab (200mg ) will be given every 3 weeks for 8 cycles.~Active Comparator: Control Nimotuzumab 200mg/week in concurrent with IMRT ."

DRUG

Gemcitabine

Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 2 cycles

DRUG

Cisplatin

"Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles.~Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles."

RADIATION

Intensity-modulated radiotherapy

Definitive IMRT of 68-78 Gy, 30-33 fractions, 5 fractions/week, 1 fraction/day

Trial Locations (9)

530000

RECRUITING

Second Affiliated Hospital of Guangzhou Medical University, Nanjing

533000

RECRUITING

People's Hospital of Baise, Baise City

533099

RECRUITING

Affiliated Hospital of Youjiang Medical University for Nationalities, Baise City

535000

RECRUITING

The First People's Hospital of Qinzhou, Qinzhou

541000

RECRUITING

Guilin Medical University, China, Guilin

RECRUITING

Nanxishan Hospital of Guangxi Zhuang Autonomous Region, Guilin

543000

RECRUITING

Wuzhou Red Cross Hospital, Wuzhou

545000

RECRUITING

Liuzhou People's Hospital, Liuzhou

Unknown

RECRUITING

the Fourth Affiliated Hospital of Guangxi Medical University, Liuzhou

All Listed Sponsors
collaborator

People's Hospital of Baise

UNKNOWN

collaborator

Second Affiliated Hospital of Guangzhou Medical University

OTHER

collaborator

People's Hospital of Guangxi Zhuang Autonomous Region

OTHER

collaborator

Guilin Medical University, China

OTHER

collaborator

LiuZhou People's Hospital

OTHER

collaborator

The First People's Hospital of Qinzhou

UNKNOWN

collaborator

Wuzhou Red Cross Hospital

OTHER

collaborator

Youjiang Medical College for Nationalities

OTHER

lead

Fourth Affiliated Hospital of Guangxi Medical University

OTHER

NCT05717790 - Concurrent and Adjuvant Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation in Nasopharyngeal Carcinoma | Biotech Hunter | Biotech Hunter