Neoadjuvant treatment for advanced bladder cancer using Toripalimab with chemotherapy

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

This study is testing if a new treatment combining Toripalimab with chemotherapy can help people with advanced bladder cancer before they have surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhujiang Hospital (Academic / other)
• Drugs / interventions: chemotherapy, prednisone, Toripalimab
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT04861584 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of neoadjuvant therapy combining Toripalimab, a checkpoint inhibitor, with gemcitabine and cisplatin in patients with locally advanced bladder cancer. Participants will receive these treatments before undergoing surgery to remove their primary tumor. The study is designed as a single-arm, open-label phase II trial, focusing on evaluating the safety and efficacy of this combination therapy. Patients will be monitored for their response to treatment and overall health status throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with locally advanced bladder urothelial carcinoma who are eligible for radical cystectomy.

Not a fit: Patients with metastatic bladder cancer or those who have previously received anti-tumor systemic treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve surgical outcomes and overall survival rates for patients with advanced bladder cancer.

How similar studies have performed: Other studies using checkpoint inhibitors in combination with chemotherapy for bladder cancer have shown promising results, indicating potential for success in this approach.

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;

Where this trial is running

Guangzhou, Guangdong

• Zhujiang Hospital — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Abai Xu, doctor — Zhujiang Hospital
• Study coordinator: Abai Xu, doctor

Conditions Urinary Bladder Cancer; bladder cancer; checkpoint inhibitor; neoadjuvant therapy