Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation

• Status: Recruiting
• Trial end date: 2029-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this Phase 2 trial is to evaluate a non-surgical bladder-preserving treatment mode which consists of induction chemotherapy plus anti-programmed cell death protein 1 (anti-PD-1) therapy followed by radiotherapy plus concurrent anti-PD-1 therapy. The main questions it aims to answer are: (i) whether the anti-PD-1 antibody, toripalimab, is effective in treating muscle-invasive bladder cancer (MIBC), when combined with chemoradiation; (ii) whether toripalimab is safe in combination with chemoradiation. Participants will receive 3 cycles of induction treatment containing chemotherapy with gemcitabine and cisplatin/carboplatin, plus toripalimab. Then the ones without progressive disease will receive radical radiotherapy plus 2 cycles of concurrent toripalimab.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Carboplatin; Gemcitabine

Criteria

Inclusion Criteria:

• Pathologically diagnosed bladder malignant tumor via biopsy

• Urothelial carcinoma as the primary histological component

• Pretreatment clinical TNM stage as T2-4aN0M0 or T1-4aN1-2M0 (UICC TNM staging classification, version 8)

• Age between 18 and 75 years old

• Karnofsky performance score ≥ 70

• Creatinine clearance rate ≥ 30 ml/min

Exclusion Criteria:

• Simultaneous tumors of the urethra or upper urinary tract

• Existence of small cell cancer component

• Uncontrolled tuberculosis, viral hepatitis or AIDS

• Autoimmune or mental diseases

• Severe cardiac, renal, hepatic or hematopoietic dysfunctions unsuitable for chemotherapy, radiotherapy or immune checkpoint inhibiting therapy

• Prior history of other malignancies within 5 years, except cured cervical carcinoma in situ and skin basal cell carcinoma

• Prior history of pelvic radiotherapy or chemotherapy

• Poor adherence to regular follow-up (cystoscopy, CT, MRI, etc.)

• Pregnant or lactating women

• Treatment with glucocorticoid or immunosuppressive drugs within 1 month

• Other situations for which the investigators consider a patient inappropriate to participate