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RC48 Combined With Toripalimab as Neoadjuvant Therapy for Cisplatin Ineligible MIBC Patients

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later May 1, 2026 → May 1, 2028
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Record History

  1. Primary completion pushed from May 1, 2026 to May 1, 2028 Completion pushed from May 1, 2027 to May 1, 2029 · Eligibility criteria expanded, about 24 words Show 2 more changesShow less
    • Completion pushed from May 1, 2027 to May 1, 2029
    • Eligibility criteria expanded, about 24 words
  2. Start date changed from estimate of May 20, 2024 to Jun 19, 2024v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Zhujiang Hospital
72 trials monitored
See 5 trials at risk
Bladder Cancer
1,022 trials monitored
See 71 trials at risk
A single-arm, prospective, exploratory clinical trial to explore the pathological complete response (pCR) rate of immune checkpoint inhibitors combined with antibody conjugate drugs as the perioperative treatment of platinum-intolerant bladder cancer patients. Fifty-five patients with clinically or pathologically confirmed muscle-invasive bladder urothelial carcinoma (MIBC) who were ineligible for cisplatin-based chemotherapy or refused cisplatin-based chemotherapy were enrolled. Each subject will receive RC48-ADC and toripalimab intravenously every 2 weeks for a total of 4 cycles before surgery, 8 cycles after surgery. The efficacy was evaluated and followed up after 4 cycles of neoadjuvant therapy, 3 months postoperative, and every 3-6 months thereafter. The primary endpoint of this study was pathological complete response rate (pCR). The secondary endpoints were to explore the safety, disease-free survival (DFS), overall survival (OS), objective response rate (ORR) and disease control rate (DCR) of RC48 combined with toripalimab neoadjuvant therapy followed by radical cystectomy.
Trial Details
NCT Number NCT06341400
Lead Sponsor Zhujiang Hospital
Conditions Bladder Cancer, Muscle-Invasive Bladder Carcinoma
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov