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NOT YET RECRUITING
NCT06327932
PHASE3

HIVEC in Patients With Non-Muscle-Invasive Bladder Cancer

Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the efficacy and safety of Hyperthermic Intravesical Chemotherapy (HIVEC) with Gemcitabine (GEM) after Transurethral Resection of Bladder Tumors (TURBT) in the treatment of medium or high-risk group Non-Muscle-Invasive Bladder Cancer (NMIBC).

Official title: A Multicenter Prospective Randomized Controlled Clinical Trial of Hyperthermic Intravesical Chemotherapy After Transurethral Resection of Bladder Tumors in Patients With Non-Muscle-Invasive Bladder Cancer

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

320

Start Date

2024-04-01

Completion Date

2028-03-31

Last Updated

2024-03-25

Healthy Volunteers

No

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).