NCT04568304View on ClinicalTrials.gov

A Study Evaluating Toripalimab Injection Combined With Standard Chemotherapy as a First-line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

364

Participants

Timeline

Start Date

November 30, 2020

Primary Completion Date

November 30, 2023

Study Completion Date

November 30, 2025

Conditions
Locally Advanced or Metastatic Urothelial Carcinoma
Interventions
BIOLOGICAL

Toripalimab Injection

Toripalimab Injection 240 mg iv infusion on Day 1 of each 3-week cycle. The cumulative duration of Toripalimab Injection is up to 2 years.

DRUG

Gemcitabine Hydrochloride for Injection

"Gemcitabine 1000mg/㎡ iv infusion, on Day 1 and Day 8 of each cycle, each treatment cycle is 3 weeks.~The chemotherapy regimen will be administered for 6 cycles."

DRUG

Cisplatin for Injection / Carboplatin Injection

"Cisplatin 70mg/㎡ iv infusion, on Day 1 or Day 2 of each cycle, each treatment cycle is 3 weeks.~Carboplatin AUC 4.5 iv infusion, on Day 1 or Day 2 of each cycle, each treatment cycle is 3 weeks.~The chemotherapy regimen will be administered for 6 cycles."

DRUG

Placebo

Placebo iv infusion on Day 1 of each 3-week cycle. The cumulative duration of placebo is up to 2 years.

Trial Locations (3)

Unknown

Peking University Cancer Hospital, Beijing

Peking University First Hospital, Beijing

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai

All Listed Sponsors
lead

Shanghai Junshi Bioscience Co., Ltd.

OTHER