RC48 Combined With Toripalimab as Neoadjuvant Therapy for Cisplatin Ineligible MIBC Patients
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Potwierdzony nowotwór pęcherza moczowego z zajęciem warstwy mięśniowej
- •Niemożność lub odmowa standardowej chemioterapii cisplatyną
- •Możliwość przejścia operacji pęcherza moczowego
- •Prawidłowe funkcjonowanie nerek, serca, wątroby i szpiku kostnego
- •Nowotwór wykazuje cechy HER2 przy badaniu mikroskopowym
- •Dla kobiet w wieku rozrodczym: zgodę na stosowanie antykoncepcji
✗ Disqualifies
- •Uczulenie na składniki leku RC48 lub toripalimab
- •Skutki uboczne poprzedniego leczenia nie ustąpiły dostatecznie
- •Płyn w opłucnej lub brzusznie wymagający stałego leczenia
- •Poważna operacja w ciągu ostatnich 4 tygodni
- •Szczepienie żywą szczepionką wirusową
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- October 8, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Zhujiang Hospital, Southern Medical University
Guangzhou, China
Trial contact
Abai Xu, doctor
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/9/2026.
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