Overview

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

Status:
Recruiting
Trial end date:
2023-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Zhujiang Hospital
Treatments:
Gemcitabine
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;