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

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.

Eligibility

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;

Conditions2

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