Actively Recruiting
RC48 Combined With Tislelizumab for Bladder Sparing Treatment in NMIBC With BCG Treatment Failure and HER2 Expression
Led by RenJi Hospital · Updated on 2023-08-31
20
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
Sponsors
R
RenJi Hospital
Lead Sponsor
R
RemeGen Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a prospective, open, single-center clinical study of anti-HER2-ADC combined with PD-1 monoclonal antibody for bladder sparing treatment in non-muscular invasive bladder cancer (NMIBC) patients with HER2-expressing. The study was conducted in accordance with the Good Clinical Practice (GCP). Approximately 20 subjects will be enrolled to evaluate the efficacy and safety of RC48 (RC48 2.0 mg/kg intravenously administered every two weeks) combined with Tislelizumab (Tislelizumab 200 mg intravenously administered every three weeks). Subjects undergo Transurethral resection of bladder tumor (TURBT), imaging diagnosis and pre-treatment biological samples of blood, urine and biopsy tissue. The study will include high-risk NMIBC patients who express HER2, fail after BCG treatment, but refuse to undergo cystectomy or do not meet the requirements for cystectomy. Subjects will receive RC48 and Tislelizumab for two years. BI-DFS were evaluated by cystoscopy, histopathologic examination, laboratory examination, and imaging examination after treatment, and tumor efficacy was evaluated when clinical studies reached the number of subjects specified in the protocol for efficacy evaluation.
CONDITIONS
Official Title
RC48 Combined With Tislelizumab for Bladder Sparing Treatment in NMIBC With BCG Treatment Failure and HER2 Expression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed recurrent non-muscle invasive bladder cancer (NMIBC)
- Includes any variant urothelial cell carcinoma with evidence of lymphatic infiltration
- High-risk papillary carcinoma (high grade Ta/T1) with all visible tumors removed before treatment
- CIS must be completely excised if coexisting with papillary carcinoma
- HER2 expression detected by immunohistochemistry
- BCG treatment failure, including no response or relapse after adequate or inadequate BCG treatment
- Patients refuse or are unsuitable for radical cystectomy
- ECOG performance status 0 to 1
- Normal major organ function including blood counts, liver, and kidney function meeting specified thresholds
- Signed informed consent form
- Fertile women must have a negative pregnancy test within 7 days before treatment
You will not qualify if you...
- Histology confirming muscular layer infiltration (T2 or higher) bladder cancer
- Presence of bladder small cell carcinoma, pure squamous cell carcinoma, or simple squamous adenocarcinoma CIS
- Prior treatment with other PD-1/PD-L1 or HER2 inhibitors
- Active malignancies other than the bladder cancer unless specifically treated and stable
- Uncontrolled cardiovascular disease or recent serious cardiac events
- Pregnancy or breastfeeding
- Known HIV infection without stable antiretroviral therapy and adequate CD4 count
- Active hepatitis B or C infection
- Ongoing toxic effects from prior cancer therapy except minor effects
- Delayed wound healing or recent major surgery within 4 weeks (excluding TURBT)
- Any other conditions judged by investigators as unsuitable for study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ethics Committee of Shanghai Renji Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
W
Wei Xue, Doctor
CONTACT
M
Ming Cao, 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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