A Phase 2 interventional study of Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin in Urinary Bladder Cancer, sponsored by Zhujiang Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by Zhujiang Hospital · Phase 2, Interventional, and Treatment
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.
Outline: This study is a single-arm, open, exploratory clinical trial;
Subjects receive: gemcitabine 1000mg/m2 IV Day1 and Day8 every 21 days repeated for 4 cycles; cisplatin 35mg/m2 IV Day1 and Day2 every 21 days, repeated for 4 cycles.
Toripalimab at recommended phase II dose is given every 3 weeks for 4 doses starting with Cycle1 Day1(C1D1).
Subjects will then have surgery to remove their primary tumor within 6 weeks after their last dose of neoadjuvant therapy.
Eastern Cooperative Oncology Group (ECOG) performance status: 0-1
Demonstrate adequate organ function as defined by the following laboratory values at study entry. All screening labs should be performed within 28 days of C1D1.
Hematopoetic:
Absolute neutrophil count (ANC) ≥1,500 /mcL Absolute lymphocyte count ≥350 mcL Platelets ≥100,000 / mcL Hemoglobin ≥9 g/dL or ≥5.6 mmol/L
Renal: Measured or calculated creatinine clearance ≥30 mL/min
Hepatic:
Serum total bilirubin ≤ 1.25 X ULN OR ≤ 2.5 x ULN for subjects with Gilbert's disease Aspartate aminotransferase (AST, SGOT) and alanine aminotransferase (ALT, SGPT) ≤ 2 X ULN
Coagulation:
International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy and as long as PT or PTT is within therapeutic range of intended use of anticoagulants
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's planned enrollment of 41 is below the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Zhujiang Hospital is the lead sponsor of 199 studies on the registry; 96 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects receive gemcitabine/cisplatin every 21 days, repeated for 4 cycles. . Toripalimab is given every 21 days for 4 doses starting C1D1. Subjects will then have consolidative surgery to remove their primary tumor within 6 weeks after their last dose of neoadjuvant therapy.
Drug: Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin
4 cycle neoadjuvant therapy and radical cystectomy
Also known as: Toripalimab
Pathological response rate evaluated after 4 cycles of neoadjuvant Toripalimab in combination with gemcitabine and cisplatin at time of radical cystectomy, each cycle is 21 days
the absence of residual muscle invasive bladder cancer in surgical specimens of cystectomy (pathologically decreased to ≤pT1N0, including pT0, pT1, pTa and pTis
Time frame: Up to 90 days after last dose of investigation product
Safety assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4 criteria
To assess safety of Toripalimab in combination with gemcitabine and cisplatin in patients with bladder cancer according to CTCAE v4 criteria
Time frame: From the first day of the treatment to the end of neoadjuvant treatment, assessed up to 6 month
Progression-free survival assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1
From the start of neoadjuvant therapy to the time when any disease progression is first recorded, disease progression includes the progression detected by clinical or imaging before cystectomy, as well as the distant metastasis or pelvic recurrence after cystectomy. Newly discovered primary tumors in other parts of the urinary tract such as renal pelvis, ureter and urethra are not considered as disease progression.
Time frame: From the start of neoadjuvant therapy to the time when any disease progression is first recorded. Assessed lasted for 24 months, calculated from the date of enrolled
Tumor immune microenvironment indicators assessed by Microenvironment Analysis Panel
The expression rate of PDL1 in pathological specimens assessed by Burning Rock's product OncoScreen plus+Microenvironment Analysis Panel at the time of surgery
Time frame: Assessed lasted for 24 months, calculated from the date of enrolled
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Zhujiang Hospital