To hear about similar clinical trials, please enter your email below
Trial Title:
HIVEC in Patients With Non-Muscle-Invasive Bladder Cancer
NCT ID:
NCT06327932
Condition:
Non-Muscle-Invasive Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
Gemcitabine
Conditions: Keywords:
Non-Muscle-Invasive Bladder Cancer
Hyperthermic Intravesical Chemotherapy
recurrence rate
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
TURBT
Description:
Transurethral Resection of Bladder Tumors
Arm group label:
HIVEC
Arm group label:
Matched control
Intervention type:
Procedure
Intervention name:
HIVEC
Description:
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.
Arm group label:
HIVEC
Intervention type:
Procedure
Intervention name:
Intravesical Chemotherapy
Description:
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.
Arm group label:
Matched control
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Gemcitabine (3g/150ml NS).
Arm group label:
HIVEC
Arm group label:
Matched control
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).
Detailed description:
In this study, patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) and planed to
undergo Transurethral Resection of Bladder Tumors (TURBT) are randomized into HIVEC group
and control group. In HIVEC group, HIVEC is performed with Gemcitabine Gemcitabine
(3g/150ml NS) at 45 °C for 60 minutes within 4 weeks, once a week (±5 days) for 6 to 8
times, once a month to 1 year. For the patients in the control group, Intravesical
Chemotherapy is administered after TURBT. The primary endpoint is 2-year recurrence rate.
Secondary end points include 1-year recurrence rate, recurrence-free survival (RFS) rate,
disease free survival (DFS) rate, time to treatment failure (TTF), Success rate of
therapeutic operation, Instrument performance evaluation, quality of international
prostate symptom score, quality of Urinary Symptoms Distress Score. All efficacy analyses
are conducted in the intention-to-treat population. Safety analysis include only patients
who receive their randomly assigned treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients who did not receive induction perfusion within 4 weeks after complete
resection of bladder tumor with TURBT (Patients who were judged by the investigator
to be in need of secondary electrotomy, for the last time).
2. Recurrence risk and prognosis of Non-Muscle-Invasive Bladder Cancer were divided
into medium-risk group or high-risk group (patients who underwent multiple
electrosurgical biopsies, and the pathological results were based on higher grade
tumors).
3. KPS score ≥80, expected survival > 30 months.
4. Pathological suggested non-myoinvasive urothelial carcinoma of the bladder.
5. Age between 18 and 70 years, all genders.
6. Volunteer to participate in this clinical trial and written informed consent.
Exclusion Criteria:
1. Patients with bladder cancer in situ.
2. Combined with proven upper urinary tract or urethral tumors.
3. The patients were complicated with bladder perforation, gross hematuria or urinary
tract infection of grade 3-4.
4. Patients with urethral discontinuity, urethral stricture, or inability to use a
three lumen catheter normally affect perfusion therapy.
5. Patients who had undergone partial cystectomy or abnormal bladder structure were
judged by the investigator to be unsuitable for perfusion therapy.
6. Patients with severe coagulation dysfunction.
7. A history of allergy to injected drugs (gemcitabine).
8. History of pelvic radiation, systemic chemotherapy, or immunotherapy.
9. Complicated with cardiovascular, cerebrovascular, hematopoietic, immune system and
other serious diseases.
10. Patients with mental illness, substance abuse, alcoholism, and inability to
cooperate.
11. Breastfeeding, pregnant, or planning to have a baby in the near future.
12. Recurrent patients with a prior history of BCG or bladder thermoperfusion therapy.
13. Participated in other clinical trials 1 month before the trial.
14. Vesicoureteral regurgitation.
15. The investigator considered it inappropriate to participate in this clinical trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
April 1, 2024
Completion date:
March 31, 2028
Lead sponsor:
Agency:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Agency class:
Other
Source:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06327932
