Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin Therapy in Local Advanced Bladder Cancer Subjects
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- STATUS
- Recruiting
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- End date
- Apr 21, 2023
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- participants needed
- 41
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- sponsor
- Zhujiang Hospital
Summary
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.
Description
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
Details
| Condition | Urinary Bladder Cancer |
|---|---|
| Treatment | Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin |
| Clinical Study Identifier | NCT04861584 |
| Sponsor | Zhujiang Hospital |
| Last Modified on | 21 March 2022 |
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