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

NCT04861584 | Recruiting Phase 2 DMC

• 1 other identifier: GZZJU-2021NB
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Bladder Cancer

Keywords

bladder cancer; checkpoint inhibitor; neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Pathological response rate evaluated after 4 cycles of neoadjuvant Toripalimab in combination with gemcitabine and cisplatin at time of radical cystectomy, each cycle is 21 days

  the absence of residual muscle invasive bladder cancer in surgical specimens of cystectomy (pathologically decreased to ≤pT1N0, including pT0, pT1, pTa and pTis

  Up to 90 days after last dose of investigation product

Secondary Outcomes (3)

• Safety assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4 criteria

  From the first day of the treatment to the end of neoadjuvant treatment, assessed up to 6 month

• Progression-free survival assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1

  From the start of neoadjuvant therapy to the time when any disease progression is first recorded. Assessed lasted for 24 months, calculated from the date of enrolled

• Tumor immune microenvironment indicators assessed by Microenvironment Analysis Panel

  Assessed lasted for 24 months, calculated from the date of enrolled

Study Arms (1)

Toripalimab+Gemcitabine/Cisplantin（GC）

EXPERIMENTAL

Subjects receive gemcitabine/cisplatin every 21 days, repeated for 4 cycles. . Toripalimab is given every 21 days for 4 doses starting C1D1. Subjects will then have consolidative surgery to remove their primary tumor within 6 weeks after their last dose of neoadjuvant therapy.

Drug: Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin

Interventions

Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin DRUG

4 cycle neoadjuvant therapy and radical cystectomy

Also known as: Toripalimab

Toripalimab+Gemcitabine/Cisplantin（GC）

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital

Guangzhou, Guangdong, 510282, China

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Gemcitabine; Cisplatin; toripalimab

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Abai Xu, doctor

  Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abai Xu, doctor

CONTACT

+86 18665626790; lc96xab@163.com

Peng Xu Xu, doctor

CONTACT

+86 18665073650; yihuixp88@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 27, 2021
• Study Start: June 3, 2021
• Primary Completion (Estimated): October 3, 2026
• Study Completion (Estimated): April 3, 2027
• Last Updated: December 4, 2024

Record last verified: 2024-03

Locations

CN (1)