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Clinical Trials in China / NCT04861584
Recruiting Phase 2

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

NCT04861584 · tracked via the Priya Life Science China tracker
Sponsor
Zhujiang Hospital
Phase
Phase 2
Started
2021-06-03
Last updated
2024-12-04

Condition(s) studied

Urinary Bladder Cancer

Investigational drug(s) / intervention(s)

Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin →

Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin: 4 cycle neoadjuvant therapy and radical cystectomy

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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;

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhujiang Hospital Guangzhou Guangdong Recruiting

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04861584 on ClinicalTrials.gov ↗ ← All trials in China