Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05957757 | RC48 Combined With Tislelizumab for Bladder Sparing Treatment in NMIBC With BCG Treatment Failure and HER2 Expression | PHASE2 | RECRUITING | 20 | — | — | Aug 5, 2023 | Jun 8, 2026 | Aug 31, 2023 | 1 | China |
Defined by time from enrollment to the occurrence of one of the following events: first MIBC or regional lymph node recurrence, distant metastasis, or death
| Arm | Type | Description |
|---|---|---|
| RC48+Tislelizumab | EXPERIMENTAL | Approximately 20 subjects will be enrolled to evaluate the efficacy and safety of RC48 (RC48 2.0 mg/kg intravenously administered every two weeks) combined with Tislelizumab (Tislelizumab 200 mg intravenously administered every three weeks). |
| Name | Type | Description |
|---|---|---|
| RC48 | DRUG | RC48 was scheduled to be administered at a dose of 2.0mg/kg every 2 weeks, with the first dose on day 1 of the first cycle. The drug is diluted with normal saline and administered by intravenous drip for one hour. |
| Tislelizumab | DRUG | Tislelizumab was administered at a dose of 200 mg every 3 weeks, with the first dose on day 1 of the first 21-day cycle. The drug is diluted with normal saline and administered by intravenous drip for one hour. |
Inclusion Criteria: 1. ≥18 years old 2. Histologically confirmed recurrent, non-muscle invasive bladder cancer; 1. Histopathology: Patients with any variant urothelial cell carcinoma (UCC) (i.e., squamous and/or glandular epithelial differentiation UCC, UCC with micropapillary changes, nest var...