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

Launched by ZHUJIANG HOSPITAL · Apr 26, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with locally advanced bladder cancer, which is cancer that has spread into surrounding tissues but not to other parts of the body. The trial is looking at a combination of three medications: Toripalimab, Gemcitabine, and Cisplatin. This treatment will be given before surgery, with the goal of shrinking the tumor and improving surgical outcomes. The trial is currently recruiting participants aged 18 to 75 who have been diagnosed with this type of cancer and are eligible for surgery.

To participate, individuals need to meet certain criteria, including having a specific type of bladder cancer confirmed by a doctor and being in reasonably good health. They will need to agree to provide some tissue samples for research and attend regular follow-up visits. Participants can expect to receive treatment and monitoring from the research team throughout the study. It’s important for potential participants to know that there are some restrictions, such as not having had prior treatments for bladder cancer or certain other health conditions. If you or someone you know is interested in participating, it’s a good idea to discuss it with a doctor.

Gender

ALL

Eligibility 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;