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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

December 1, 2023

Primary Completion Date

August 31, 2025

Study Completion Date

December 31, 2029

Conditions
Muscle-Invasive Bladder CarcinomaProgrammed Cell Death Protein 1 InhibitorRadiotherapy
Interventions
DRUG

Toripalimab

"The patients in this arm 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.~Toripalimab: 240 mg on Day 1, every 3 weeks, totally 3 and 2 cycles in the induction and concurrent phases, respectively."

DRUG

Gemcitabine

"The patients in this arm 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.~Gemcitabine: 1 g/m2 on Days 1 and 8, repeated every 3 weeks, totally 3 cycles."

DRUG

Cisplatin

"The patients in this arm 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.~Cisplatin: Used when creatinine clearance rate ≥ 40 ml/min, 37.5 mg/m2 on Days 1 and 2, repeated every 3 weeks, totally 3 cycles."

DRUG

Carboplatin

"The patients in this arm 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.~Cisplatin: Used when creatinine clearance rate \< 40 ml/min, area under curve = 2 on Days 1 and 2, repeated every 3 weeks, totally 3 cycles."

RADIATION

Intensity-modulated radiation therapy

"The patients in this arm 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.~Radiotherapy: performed by using the technique of intensity-modulated radiation therapy, with a total dose of 65 and 45 Gy for the gross tumor and lymphatic drainage regions."

Trial Locations (1)

510060

Cancer Center, Sun Yat-sen University, Guangzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER

NCT05975307 - Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation | Biotech Hunter | Biotech Hunter