Suspended
A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection (JS001) in Combination With Standard Chemotherapy Versus Placebo in Combination With Standard Chemotherapy as the 1st-line Therapy for Treatment-naive Subjects With PD-L1-positive Locally Advanced or Metastatic Urothelial Carcinoma
What is being tested
Toripalimab Injection
+ Gemcitabine Hydrochloride for Injection
+ Cisplatin for Injection / Carboplatin Injection
BiologicalDrug
Who is being recruted
Carcinoma+2
+ Carcinoma, Transitional Cell
+ Neoplasms
From 18 to 75 Years
+16 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 3
Interventional
Study Start: November 2020
Summary
Principal SponsorShanghai Junshi Bioscience Co., Ltd.
Study ContactJun Guo, Prof
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Study start date: November 30, 2020
Actual date on which the first participant was enrolled.The study is being conducted to evaluate the efficacy and safety of Toripalimab Injection in combination with chemotherapy compared to placebo in combination with chemotherapy in subjects with PD-L1-positive unresectable locally advanced or metastatic urothelial carcinoma who have received no previous systemic therapy.
Official TitleA Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection (JS001) in Combination With Standard Chemotherapy Versus Placebo in Combination With Standard Chemotherapy as the 1st-line Therapy for Treatment-naive Subjects With PD-L1-positive Locally Advanced or Metastatic Urothelial Carcinoma
Principal SponsorShanghai Junshi Bioscience Co., Ltd.
Study ContactJun Guo, Prof
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
364 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
CarcinomaCarcinoma, Transitional CellNeoplasmsNeoplasms by Histologic TypeNeoplasms, Glandular and Epithelial
Criteria
9 inclusion criteria required to participate
Have full knowledge on this study and are willing to sign informed consent form (ICF);
Age 18-75 years at time of signing ICF, male or female;
The investigator judged that the subject is eligible for platinum-based chemotherapy;
Presence of histopathologically confirmed unresectable locally advanced (T4, any N; or any T, N2-3) or metastatic urothelial carcinoma;
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7 exclusion criteria prevent from participating
Have received anti-tumor treatments, including chemotherapy, radiotherapy or investigational product within 28 days before randomization;
Have received traditional Chinese medicines with anti-tumor activity or immunomodulators (eg. Interferon and Interleukin) within 14 days before randomization;
Previous use of anti-PD-1/PD-L1 agent or a drug acting on another co-inhibitory T cell receptor;
Subjects who are currently participating in or have participated in a study with investigational product within 4 weeks before administration;
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Suspended
Peking University Cancer Hospital
Beijing, ChinaOpen Peking University Cancer Hospital in Google MapsSuspended
Peking University First Hospital
Beijing, ChinaSuspended
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, ChinaSuspended3 Study Centers