Trial · NCT07189793
Toripalimab ± Sequential Intravesical Gemcitabine-Mitomycin C for BCG-Unresponsive/-Intolerant High-Risk NMIBC: Open-Label Randomized Phase 2 Study
NCT07189793, Phase 2, Not yet recruiting, First Affiliated Hospital of Wenzhou Medical University
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Toripalimab ± Sequential Intravesical Gemcitabine-Mitomycin C for BCG-Unresponsive/-Intolerant High-Risk NMIBC: Open-Label Randomized Phase 2 Study. Trials, record NCT07189793. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07189793
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Toripalimab ± Sequential Intravesical Gemcitabine-Mitomycin C for BCG-Unresponsive/-Intolerant High-Risk NMIBC: Open-Label Randomized Phase 2 Study
- NCT number
- NCT07189793
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 106 participants, estimated
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical University
- Conditions
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Carcinoma in Situ of Bladder, Non-Muscle-Invasive Bladder Cancer
- Interventions
- Toripalimab, Gemcitabine (GEM), Mitomycin C (MMC)
- First posted
- 2025-09-24
- Last updated
- 2026-09-08
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response (CR) Rate at Month 3 in the CIS Cohort | Baseline to Month 3 | Proportion of participants in the CIS cohort achieving CR at month 3. CR is met by any of the following protocol-specified scenarios indicating no high-grade bladder disease: (a) negative urine cytology and negative cystoscopy; (b) negative cytology with cystoscopic lesions that are benign or low-grade Ta on biopsy; or (c) negative cystoscopy with positive cytology attributed to tumour in the upper tract or prostatic urethra and random bladder biopsies negative. |
| Primary | Median Recurrence-Free Survival (RFS) in the Non-CIS Cohort | From randomisation/start of treatment to first event, assessed up to 24 months | RFS is time to high-grade Ta recurrence, any T1, or new CIS, whichever occurs first. Recurrence requires cystoscopic suspicion confirmed by histopathology; if cytology becomes positive before histologic confirmation, the recurrence date is set at the first positive cytology once recurrence is subsequently confirmed. Death from any cause before documented recurrence is counted as an event. |
| Secondary | CR Rates at Months 6, 12, 18, and 24 in the CIS Cohort | Baseline to months 6, 12, 18, and 24 | Proportion of participants in the CIS cohort with CR at the specified time points using the protocol CR definition. |
| Secondary | Progression-Free Survival (PFS) Rates at Months 6, 12, 18, and 24 in the CIS Cohort | Baseline to months 6, 12, 18, and 24 | Proportion without progression at each time point. Progression is defined as lamina propria invasion from Ta/CIS to T1, or progression to ≥T2, or new nodal or distant metastasis. |
| Secondary | Overall Survival at Month 24, EOT+6 Months, and EOT+12 Months in the CIS Cohort | Baseline to Month 24, EOT+6 months, and EOT+12 months | Survival status at prespecified landmarks. |
| Secondary | Incidence of Adverse Events in the CIS Cohort | From first dose/instillation to 90 days post-last dose/instillation (≈ up to 27 months) | Participants with treatment-emergent AEs and grade ≥3 AEs (MedDRA; CTCAE v5.0). Immune-related and instillation-related events summarised. |
| Secondary | Recurrence-Free Survival Rates at Months 6, 12, 18, and 24 in the Non-CIS Cohort | Baseline to months 6, 12, 18, and 24 | Proportion without recurrence (high-grade Ta, any T1, or new CIS) or death at each time point; recurrence confirmation rules per protocol. |
| Secondary | High-Grade Recurrence-Free Survival (HG-RFS) Rates at Months 6, 12, 18, and 24 in the Non-CIS Cohort | Baseline to months 6, 12, 18, and 24 | Proportion without high-grade recurrence at each time point. High-grade recurrence is defined as Tis or Ta/T1 high-grade, or muscle-invasive disease identified at TURBT or cystectomy. |
| Secondary | Progression-Free Survival Rates at Months 6, 12, 18, and 24 in the Non-CIS Cohort | Baseline to Months 6, 12, 18, and 24 | Proportion without progression (lamina propria invasion from Ta/CIS to T1, progression to ≥T2, or new nodal/distant metastasis). Death before documented progression counts as an event. |
| Secondary | Overall Survival at Month 24, EOT+6 Months, and EOT+12 Months in the Non-CIS Cohort | Baseline to Month 24, EOT+6 months, and EOT+12 months | Survival status at prespecified landmarks. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07189793
GET https://conductscience.org/api/trials/v1/NCT07189793/registered