Tests toripalimab with gemcitabine and cisplatin before bladder cancer surgery

Trial details

Who runs it

Zhujiang Hospital

Trial code

NCT04861584

Record updated

9 October 2026

Original description

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.Read full original descriptionShow less

Phase II Study of Neoadjuvant Toripalimab With Gemcitabine-Cisplatin in Subjects With T2-4aN0M0 Bladder Cancer: GZZJU-2021NB

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.

Inclusion: 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: 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; 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; Kidney transplant patients; Patients with any history of active autoimmune disease or autoimmune disease; 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.

ClinicalTrials.gov NCT04861584