RecruitingPhase 1Phase 2NCT06341400

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

Perioperative Efficacy of RC48 Combined with Toripalimab in Treatment of Cisplatin Ineligible MIBC

Sponsor

Zhujiang Hospital

Enrollment

55 participants

Start Date

Jun 19, 2024

Study Type

INTERVENTIONAL

Conditions

Muscle-Invasive Bladder Carcinoma Bladder Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two cancer drugs — RC48 (an antibody-drug conjugate targeting HER2) and toripalimab (an immunotherapy) — given before bladder removal surgery in patients with muscle-invasive bladder cancer who cannot tolerate standard cisplatin chemotherapy. **You may be eligible if...** - You are 18 or older with muscle-invasive bladder cancer - You cannot receive cisplatin because of kidney problems, nerve damage, hearing loss, or personal preference - Your tumor tests positive for the HER2 protein - You are healthy enough to undergo surgery to remove the bladder - Your heart, liver, kidney, and blood counts are within acceptable ranges **You may NOT be eligible if...** - You have known allergy to RC48 or toripalimab - You have active HIV, tuberculosis, or active hepatitis B or C infection - The cancer has spread to your brain - You have uncontrolled high blood pressure, diabetes, or serious lung disease - You are currently pregnant or breastfeeding - You have had another cancer in the past 5 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDisitamabVedotinForIicction Toripalimab

Each subject will receive RC48-ADC 2.0mg/kg and toripalimab 3.0mg/kg intravenously every 2 weeks for a total of 4 cycles. RC48-ADC 2.0mg/kg and toripalimab 3.0mg/kg were intravenously infused every 2 weeks for 8 cycles.