Neoadjuvant Toripalimab in Combination with Gemcitabine and Cisplatin Therapy in Local Advanced Bladder Cancer Subjects
NCT ID: NCT04861584
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
41 participants
INTERVENTIONAL
2021-06-03
2027-04-03
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Toripalimab+Gemcitabine/Cisplantin（GC）
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.
Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin
4 cycle neoadjuvant therapy and radical cystectomy
Interventions
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Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin
4 cycle neoadjuvant therapy and radical cystectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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;
18 Years
75 Years
ALL
No
Sponsors
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Zhujiang Hospital
OTHER
Responsible Party
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Abai Xu
Vice Director
Principal Investigators
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Abai Xu, doctor
Role: PRINCIPAL_INVESTIGATOR
Zhujiang Hospital
Locations
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Zhujiang Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Peng Xu
Role: primary
Other Identifiers
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GZZJU-2021NB
Identifier Type: -
Identifier Source: org_study_id