OncoMatch/Clinical Trials/NCT06341400
RC48 Combined with Toripalimab As Neoadjuvant Therapy for Cisplatin Ineligible MIBC Patients
Is NCT06341400 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies DisitamabVedotinForIicction Toripalimab for bladder cancer.
Treatment: DisitamabVedotinForIicction Toripalimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (ihc ≥1+)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Blood counts
Hemoglobin ≥9 g/dL; Absolute neutrophil count ≥ 1.5×10^9 /L and platelet ≥ 100×10^9 /L
Kidney function
Creatinine clearance (CrCl) <60 mL/min (cisplatin ineligible); Creatinine clearance (CrCl) ≥ 60 mL/min (ECOG PS 2, if eligible for RC)
Liver function
Total bilirubin ≤ 1.5× ULN; AST and ALT ≤ 2.5×ULN and ≤ 5×ULN.
Cardiac function
heart ejection fraction was ≥50%
The heart ejection fraction was ≥50%. Hemoglobin ≥9 g/dL; Absolute neutrophil count ≥ 1.5×10^9 /L and platelet ≥ 100×10^9 /L; Total bilirubin ≤ 1.5× ULN; AST and ALT ≤ 2.5×ULN and ≤ 5×ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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