RC48 Combined with Toripalimab As Neoadjuvant Therapy for Cisplatin Ineligible MIBC Patients

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 surge

Trial Details

NCT ID
NCT06341400
Phase
PHASE1 / PHASE2
Sponsor
Zhujiang Hospital
Status
RECRUITING
Cancer Type
Urothelial Carcinoma Bladder Cancer
Interventions
  • DisitamabVedotinForIicction Toripalimab
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

  • Voluntarily agree to provide written informed consent.
  • Male or female, aged ≥18 years old.
  • Patients must be ineligible for cisplatin-based chemotherapy or refuse cisplatin-based chemotherapy because of any of the following:
  • Creatinine clearance (CrCl) \<60 mL/min, ECOG performance status (PS) 0-1 Creatinine clearance (CrCl) ≥ 60 mL/min, ECOG PS 2 (if the patient is eli…

For full eligibility, visit ClinicalTrials.gov.

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