Locally Advanced or Metastatic Urothelial CarcinomaPhase 3NCT04568304
A Study Evaluating Toripalimab Injection Combined With Standard Chemotherapy as a First-line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma
A Phase 3 study testing Toripalimab Injection, Gemcitabine Hydrochloride for Injection and Cisplatin for Injection / Carboplatin Injection in people with Locally Advanced or Metastatic Urothelial Carcinoma, run by Shanghai Junshi Bioscience Co., Ltd. at 3 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced or Metastatic Urothelial Carcinoma
- What is being tested?
- Toripalimab Injection, Gemcitabine Hydrochloride for Injection and Cisplatin for Injection / Carboplatin Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesChina
- Study dates
- 6 Sep 2022to 6 Sep 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- No prior systemic anti-tumor therapy;
- Subjects who are able to provide tumor tissue slides (≥ 5 slides) for PD-L1 test and the corresponding pathology report and whose PD-L1 test must be positive before randomization;
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- With at least one measurable lesion as per RECIST 1.1 criteria;
- ECOG performance status score of 0-1;
- Adequate function of vital organs.
Who cannot join
- 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;
- Having received systemic corticosteroid therapy (dose equivalent to prednisone > 10 mg/day) within 14 days before randomization;
- Subjects with active central nervous system (CNS) metastasis;
- Grade 2 or higher peripheral neuropathy or hearing loss.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Peking University Cancer Hospital
Beijing
Peking University First Hospital
Beijing
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai
About this study
Official title: 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
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.
- Being tested
- Toripalimab Injection, Gemcitabine Hydrochloride for Injection, Cisplatin for Injection / Carboplatin Injection, Placebo
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toripalimab InjectionBiological
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.
Gemcitabine Hydrochloride for InjectionDrug
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.
Cisplatin for Injection / Carboplatin InjectionDrug
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.
PlaceboDrug
Placebo iv infusion on Day 1 of each 3-week cycle. The cumulative duration of placebo is up to 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab Injection + chemotherapy group | Experimental | Not described Receives: Biological: Toripalimab Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: Cisplatin for Injection / Carboplatin Injection |
| Placebo + chemotherapy group | Placebo comparator | Not described Receives: Drug: Gemcitabine Hydrochloride for Injection; Drug: Cisplatin for Injection / Carboplatin Injection; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator-assessed progression-free survival (INV-PFS) as per RECIST 1.1 criteria
To evaluate the investigator-assessed progression-free survival following 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
Measured: Approximately 3 years
Secondary outcomes (10)
IRC-PFS
Independent central radiological review committee-assessed progression-free survival as per RECIST1.1 criteria
Measured: Approximately 3 years
INV-ORR, IRC-ORR
Investigator- and IRC-assessed overall response rate
Measured: Approximately 3 years
INV-DCR, IRC-DCR
Investigator- and IRC-assessed disease control rate
Measured: Approximately 3 years
INV-DoR, IRC- DoR
Investigator- and IRC-assessed duration of response
Measured: Approximately 3 years
OS
Overall survival
Measured: Approximately 5 years
OS rate at 1 year
Overall survival rate at 1 year
Measured: Approximately 3 years
OS rate at 2 years
Overall survival rate at 2 years
Measured: Approximately 4 years
INV-PFS rate and IRC-PFS rate at 6 months
Investigator- and IRC-assessed progression-free survival rate at 6 months
Measured: Approximately 2.5 years
INV-PFS rate and IRC-PFS rate at 1 year
Investigator- and IRC-assessed progression-free survival rate at 1 year
Measured: Approximately 3 years
Incidence of AEs/SAEs
Study drug related adverse events, serious adverse events graded in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0
Measured: Approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start6 Sep 2022
- Primary completion6 Sep 2022
- Study completion6 Sep 2022
Why it stopped: This study was not conducted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Urothelial CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568304
- Sponsor's protocol ID
- JS001-038-III-UBC
- Status last verified
- Jul 2026
- First submitted
- 17 Sep 2020
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04568304
- Acronym / sponsor ID
- JS001-038-III-UBC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was not conducted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 6 Sep 2022 (actual)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toripalimab Injection + chemotherapy group | Experimental | Biological: Toripalimab Injection, Drug: Gemcitabine Hydrochloride for Injection, Drug: Cisplatin for Injection / Carboplatin Injection |
| Placebo + chemotherapy group | Placebo comparator | Drug: Gemcitabine Hydrochloride for Injection, Drug: Cisplatin for Injection / Carboplatin Injection, Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
- No prior systemic anti-tumor therapy;
Key exclusion criteria (7 listed)
- 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;
- Having received systemic corticosteroid therapy (dose equivalent to prednisone > 10 mg/day) within 14 days before randomization;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toripalimab InjectionToripalimab Injection 240 mg iv infusion on Day 1 of each 3-week cycle. The cumulative duration of Toripalimab Injection is up to 2 years. | Biological | Toripalimab Injection + chemotherapy group |
| Gemcitabine Hydrochloride for InjectionGemcitabine 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 | Placebo + chemotherapy group, Toripalimab Injection + chemotherapy group |
| Cisplatin for Injection / Carboplatin InjectionCisplatin 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 + chemotherapy group, Toripalimab Injection + chemotherapy group |
| PlaceboPlacebo iv infusion on Day 1 of each 3-week cycle. The cumulative duration of placebo is up to 2 years. | Drug | Placebo + chemotherapy group |
Primary outcome
Investigator-assessed progression-free survival (INV-PFS) as per RECIST 1.1 criteria
Time frame: Approximately 3 years
To evaluate the investigator-assessed progression-free survival following 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
10 secondary outcomes
IRC-PFS
Time frame: Approximately 3 years
INV-ORR, IRC-ORR
Time frame: Approximately 3 years
INV-DCR, IRC-DCR
Time frame: Approximately 3 years
INV-DoR, IRC- DoR
Time frame: Approximately 3 years
OS
Time frame: Approximately 5 years
OS rate at 1 year
Time frame: Approximately 3 years
OS rate at 2 years
Time frame: Approximately 4 years
INV-PFS rate and IRC-PFS rate at 6 months
Time frame: Approximately 2.5 years
INV-PFS rate and IRC-PFS rate at 1 year
Time frame: Approximately 3 years
Incidence of AEs/SAEs
Time frame: Approximately 4 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Toripalimab Injection, Gemcitabine Hydrochloride for Injection and Cisplatin for Injection / Carboplatin Injection in people with Locally Advanced or Metastatic Urothelial Carcinoma, run by Shanghai Junshi Bioscience Co., Ltd. at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator-assessed progression-free survival (INV-PFS) as per RECIST 1.1 criteria (time frame: Approximately 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.