Actively Recruiting
RC48 Combined with Toripalimab As Neoadjuvant Therapy for Cisplatin Ineligible MIBC Patients
Led by Zhujiang Hospital · Updated on 2024-12-04
55
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RC48 Combined with Toripalimab As Neoadjuvant Therapy for Cisplatin Ineligible MIBC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to provide written informed consent
- Male or female, aged 18 years or older
- Ineligible for cisplatin-based chemotherapy or refuse cisplatin-based chemotherapy due to creatinine clearance less than 60 mL/min, ECOG performance status 0-1, ECOG PS 2 if eligible for radical cystectomy, hearing impairment CTCAE level 2 or higher, neuropathy grade 2 or higher, or patient declined chemotherapy
- Medically suitable for transurethral resection of bladder tumor (TURBT) and radical cystectomy (RC)
- Pathological examination with immunohistochemical Her-2 expression of 1+ or higher
- Measurable lesions according to RECIST 1.1
- Adequate organ function within 7 days before treatment including heart ejection fraction 50% or higher; hemoglobin 9 g/dL or higher; absolute neutrophil count 1.5x10^9/L or higher; platelet count 100x10^9/L or higher; total bilirubin 1.5 times upper limit of normal or lower; AST and ALT 2.5 times upper limit of normal or lower, and 5 times upper limit of normal or lower
- Female subjects of childbearing potential must agree to use highly effective contraception; males and their female partners must also agree to use highly effective contraception
- Willing to comply with study schedule and restrictions
You will not qualify if you...
- Known hypersensitivity to recombinant humanized anti-HER2 monoclonal antibody-MMAE conjugate or allergic reaction to toripalimab
- Toxicity from previous antineoplastic therapy not resolved to CTCAE grade 0-1 except grade 2 alopecia
- Pleural or abdominal effusion with symptoms requiring ongoing treatment
- Major surgery within 4 weeks before planned trial treatment
- Received live virus vaccine within 4 weeks before planned trial treatment
- Active HIV or tuberculosis infection
- Positive for HBsAg, HBcAb with HBV DNA positive, or HCV antibody positive
- Any condition, treatment, or lab abnormality that may interfere with participation or trial results as judged by investigator
- History of other malignancies within past 5 years
- Known central nervous system metastases
- Uncontrolled hypertension, diabetes, interstitial lung disease, or chronic obstructive pulmonary disease
- Systemic therapy for autoimmune disease within 2 years before study treatment
- NYHA class III heart failure
- Pregnancy or lactation
- Unable or unwilling to comply with protocol requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
A
Abai Xu, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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