Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin Therapy in Local Advanced Bladder Cancer Subjects

  • STATUS
    Recruiting
  • End date
    Apr 21, 2023
  • participants needed
    41
  • sponsor
    Zhujiang Hospital
Updated on 21 March 2022
radical cystectomy
measurable disease
carcinoma
gemcitabine
bladder tumor

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 IdentifierNCT04861584
SponsorZhujiang Hospital
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients between 18 and 75 years old on day of signing informed consent, regardless of gender
ECOG score 0-1 points, expected survival time> 6 months
Pathologically confirmed locally advanced bladder urothelial carcinoma (cT2-T4a, N≤1, M0, tumor staging according to American Joint Committee on Cancer (AJCC), 2017, eighth edition)
Appropriate and plan for radical cystectomy
According to the RECIST1.1 standard, there is at least one measurable lesion (spiral CT scan ≥10mm)
Since the diagnosis of locally advanced bladder urothelial carcinoma, patient has not received anti-tumor system treatment
The main organ functions are normal, and the following requirements must be met within 2 weeks before the first study treatment
Routine blood examination must meet: WBC≥4.0×109/L; PLT≥90×109/L; Hb≥90g/L (patients can be infused with red blood cells to meet this standard)
Blood biochemical examination must meet: serum creatinine (Cr) ≤1.5 times the upper limit of normal (ULN) or endogenous creatinine clearance ≥60mL/min; TBIL≤1.5×ULN; ALB≥30g/L; ALT and AST≤ 3.0×ULN; TSH≤1.5×ULN
Female patients with fertility must undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and they voluntarily adopt appropriate methods of contraception during the observation period and within 8 weeks after the last administration
Agree to provide diagnosis and treatment-related tumor tissue specimens for clinical research, and have the ability to follow the planned research visit until the clinical recurrence/progress is clear
Sign informed consent voluntarily

Exclusion Criteria

Have previously received anti-PD1/PDL1/CTLA-4 antibody treatment or systemic chemotherapy, bladder infusion chemotherapy is excluded
Have received bladder bacille Calmette Guerin (BCG) infusion therapy within 4 weeks
Have received radiotherapy of the bladder in the past
Patients with any history of active autoimmune disease or autoimmune disease
Complicated diseases that require the use of immunosuppressive drugs; concurrent diseases that require the use of immunosuppressive agents for systemic or locally absorbable corticosteroids. It is forbidden to use prednisone greater than 10 mg/day or the same dose in the 2 weeks before the use of the study drug
Combined with other malignant tumors
Have a history of allergy to other antibody drugs
The history of human immunodeficiency virus (HIV) infection
The subject has active infection, including active tuberculosis
Combined with severe heart disease, or combined with New York Heart Association (NYHA) grade 3 or 4 cardiac insufficiency
Kidney transplant patients
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