Actively Recruiting
Phase II Study of Neoadjuvant Toripalimab with Gemcitabine-Cisplatin in Subjects with T2-4aN0M0 Bladder Cancer: GZZJU-2021NB
Led by Zhujiang Hospital · Updated on 2024-12-04
41
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of neoadjuvant toripalimab combined with gemcitabine and cisplatin in people with locally advanced bladder cancer, specifically those who are candidates for neoadjuvant therapy before surgery. This is a phase II, single-arm clinical trial focused on assessing the pathological response rate after treatment and surgery. The study aims to better understand the effects of this combination therapy prior to radical cystectomy. Participants receive gemcitabine at 1000 mg/m2 intravenously on Days 1 and 8 every 21 days for 4 cycles, along with cisplatin at 35 mg/m2 intravenously on Days 1 and 2 every 21 days for 4 cycles. Toripalimab is given at a recommended phase II dose every 3 weeks for 4 doses starting on Cycle 1 Day 1. After completing these treatments, patients undergo surgery to remove the primary tumor within 6 weeks. During the study, participants are monitored with laboratory tests to ensure adequate organ function before treatment begins. Researchers evaluate the pathological response rate after neoadjuvant therapy at the time of surgery. Safety is monitored using standard criteria up to 6 months after treatment, and progression-free survival and tumor immune environment indicators are assessed for up to 24 months. Overall participation lasts until these assessments are complete, with careful follow-up throughout.
CONDITIONS
Brief 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 time greater than 6 months
- Pathologically confirmed locally advanced bladder urothelial carcinoma (cT2-T4a, N≤1, M0) according to AJCC 2017 staging
- Planned and appropriate for radical cystectomy surgery
- At least one measurable lesion of 10 mm or larger by spiral CT scan per RECIST1.1
- No prior anti-tumor systemic treatment since diagnosis of locally advanced bladder urothelial carcinoma
- Adequate organ function within 2 weeks before first study treatment: WBC ≥4.0×10⁹/L, Platelets ≥90×10⁹/L, Hemoglobin ≥90 g/L (may receive red blood cell transfusion to meet this)
- Blood biochemistry within limits: serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min; total bilirubin ≤1.5×ULN; albumin ≥30 g/L; ALT and AST ≤3.0×ULN; TSH ≤1.5×ULN
- Negative pregnancy test within 7 days before enrollment for women of childbearing potential and agreement to use contraception during and 8 weeks after treatment
- Agreement to provide tumor tissue samples for research and ability to attend planned visits until clinical recurrence or progression is clear
- Signed informed consent voluntarily
You will not qualify if you...
- Prior treatment with anti-PD1, PDL1, CTLA-4 antibodies or systemic chemotherapy (bladder infusion chemotherapy excluded)
- Bladder bacille Calmette Guerin (BCG) infusion therapy within 4 weeks before study
- Previous radiotherapy to the bladder
- History of active autoimmune disease
- Diseases requiring immunosuppressive drugs or corticosteroids above prednisone 10 mg/day within 2 weeks before study drug use
- Presence of other malignant tumors
- History of allergy to antibody drugs
- HIV infection history
- Active infections including active tuberculosis
- Severe heart disease or NYHA class 3 or 4 heart failure
- History of kidney transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - Approximately 12 weeks (4 cycles of 21 days each)
Participants receive neoadjuvant therapy with toripalimab combined with gemcitabine and cisplatin over four 21-day cycles.
Multiple visits every 3 weeks for 4 doses of toripalimab and gemcitabine/cisplatin on Days 1 and 8 of each cycle
Duration - Up to 6 weeks
Participants undergo surgery to remove their primary tumor within 6 weeks following the last dose of neoadjuvant therapy.
1 surgical visit (in-person)
Trial Site Locations
Total: 1 location
1
Zhujiang Hospital
Guangzhou, Guangdong, China, 510282
Actively Recruiting
Research Team
A
Abai Xu, doctor
P
Peng Xu Xu, doctor
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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