Overview

Phase III Study of Comparing TORIPALIMAB INJECTION Versus Placebo Combined With Chemotherapy for Recurrent or Metastatic Nasophapyngeal Cancer

Status:
Completed
Trial end date:
2020-10-30
Target enrollment:
Participant gender:
Summary
This is a randomized, placebo-controlled, multi-center, double blinded, Phase III study to determine the efficacy and safety of TORIPALIMAB INJECTIO（JS001） in combination with gemcitabine/cisplatin compared with placebo in combination with gemcitabine/cisplatin as first-line treatment in patients with histological/cytological confirmation of recurrent or metastatic NPC. The primary endpoint is PFS in all patients. Approximately 280 patients who fulfill all of the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to one of the two treatment arms. patients will be randomly assigned to the combination of JS001 (Arm A) or placebo (Arm B) with gemcitabine and cisplatin given every 3 weeks (Q3W) in 3-week cycles.
Phase:
Phase 3
Details
Lead Sponsor:
Shanghai Junshi Bioscience Co., Ltd.
Shanghai Junshi Bioscience Co.,Ltd.