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Clinical Trial 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.

Clinical Trial 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. Teriprizumab 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 ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04861584
Study type Interventional
Source Zhujiang Hospital
Contact Abai Xu, doctor
Phone +86 18665626790
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date April 2021
Completion date April 2023

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