Actively Recruiting
Neoadjuvant Toripalimab in Combination with Gemcitabine and Cisplatin Therapy in Local Advanced Bladder Cancer Subjects
Led by Zhujiang Hospital · Updated on 2024-12-04
41
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a pre-surgical study involving subjects with local advanced bladder cancer, who are candidates for neoadjuvant therapy. It is a single-arm phase II portion.
CONDITIONS
Official Title
Neoadjuvant Toripalimab in Combination with Gemcitabine and Cisplatin Therapy in Local Advanced Bladder Cancer Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients between 18 and 75 years old on day of signing informed consent, regardless of gender
- ECOG performance status of 0 or 1 with expected survival over 6 months
- Pathologically confirmed locally advanced bladder urothelial carcinoma (cT2-T4a, N0-1, M0) according to AJCC 2017
- Planned radical cystectomy surgery
- At least one measurable lesion of 10 mm or more by spiral CT scan per RECIST1.1
- No prior anti-tumor systemic treatment since diagnosis
- Adequate blood counts: WBC 64 4.0 x 10^9/L; platelets 64 90 x 10^9/L; hemoglobin 64 90 g/L (transfusion allowed to meet standard)
- Adequate blood biochemistry within 2 weeks before treatment: creatinine 64 1.5 x ULN or creatinine clearance 60 mL/min; total bilirubin 64 1.5 x ULN; albumin 64 30 g/L; ALT and AST 64 3.0 x ULN; TSH 64 1.5 x ULN
- Female patients with fertility must have a negative pregnancy test within 7 days before enrollment and agree to use contraception during and for 8 weeks after treatment
- Agree to provide tumor tissue samples and follow scheduled visits until clinical recurrence or progression
- Provide voluntary informed consent
You will not qualify if you...
- Prior treatment with anti-PD1, anti-PDL1, anti-CTLA-4 antibodies, or systemic chemotherapy (bladder infusion chemotherapy excluded)
- Bladder BCG infusion therapy within 4 weeks before study entry
- Prior radiotherapy to the bladder
- History of any active autoimmune disease
- Need for immunosuppressive drugs or corticosteroids exceeding prednisone 10 mg/day within 2 weeks before study drug use
- Presence of other malignant tumors
- Allergy history to antibody drugs
- History of HIV infection
- Active infections including active tuberculosis
- Severe heart disease or NYHA class 3 or 4 heart failure
- Kidney transplant recipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhujiang Hospital
Guangzhou, Guangdong, China, 510282
Actively Recruiting
Research Team
A
Abai Xu, doctor
CONTACT
P
Peng Xu 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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here