HIVEC in Patients With Non-Muscle-Invasive Bladder Cancer

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

320

Participants

Timeline

Start Date

April 1, 2024

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2028

Conditions
Non-Muscle-Invasive Bladder Cancer
Interventions
PROCEDURE

TURBT

Transurethral Resection of Bladder Tumors

PROCEDURE

HIVEC

Hyperthermic Intravesical Chemotherapy with Gemcitabine (3g/150ml NS) at 45 °C for 60 minutes. Induction perfusion was required to start within 4 weeks, once a week (±5 days) for 6 to 8 times. After the last induction infusion, maintenance infusion was performed, once every month (±2 weeks) for 1 year from the first induction infusion.

PROCEDURE

Intravesical Chemotherapy

Intravesical Chemotherapy with Gemcitabine (3g/150ml NS). Induction perfusion was required to start within 4 weeks, once a week (±5 days) for 6 to 8 times. After the last induction infusion, maintenance infusion was performed, once every month (±2 weeks) for 1 year from the first induction infusion.

DRUG

Gemcitabine

Gemcitabine (3g/150ml NS).

All Listed Sponsors
lead

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

OTHER