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HIVEC in Patients With Non-Muscle-Invasive Bladder Cancer

NCT06327932 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2024-03-25

No results posted yet for this study

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).

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).

Sponsors & Collaborators

  • Affiliated Cancer Hospital & Institute of Guangzhou Medical University

    lead OTHER

Principal Investigators

  • Shuzhong Cui, MD · Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2026-03-31
Completion
2028-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06327932 on ClinicalTrials.gov