RecruitingPhase 2NCT04861584

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

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

Sponsor

Zhujiang Hospital

Enrollment

41 participants

Start Date

Jun 3, 2021

Study Type

INTERVENTIONAL

Conditions

Urinary Bladder Cancer

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria12

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 Criteria11

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;