An Open-label, Multicentre, Phase II/III RCT of PFLL Versus GP Combined With JS001 as the First-line Therapy for mNPC

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

622

Participants

Timeline

Start Date

July 1, 2021

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2028

Conditions
Nasopharyngeal CarcinomaMetastasisChemotherapyImmunotherapySurvival
Interventions
DRUG

Triprilimab(JS001)

Maximum 6 cycles for combined therapy and maintenance for up to 2 years.

DRUG

Cisplatin

Maximum 6 cycles for combined therapy.

DRUG

5-Fluorouracil

Maximum 6 cycles for combined therapy.

DRUG

Gemcitabine

Maximum 6 cycles for combined therapy.

Trial Locations (1)

510060

Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Guangzhou

All Listed Sponsors
collaborator

Shanghai Junshi Bioscience Co., Ltd.

OTHER

lead

Sun Yat-sen University

OTHER

NCT04890522 - An Open-label, Multicentre, Phase II/III RCT of PFLL Versus GP Combined With JS001 as the First-line Therapy for mNPC | Biotech Hunter | Biotech Hunter