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

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhujiang Hospital
• Treatments: Gemcitabine

Criteria

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;