NCT06327932Not yet recruitingPhase 3
HIVEC in Patients With Non-Muscle-Invasive Bladder Cancer
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
Source: ClinicalTrials.gov · Last updated 25 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- First submitted
- 7 Mar 2024
- Start date
- 1 Apr 2024
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Diseases
- Bladder cancer
- NCT number
- NCT06327932
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 320
- From 1 Apr 2024 to the primary completion date, 31 Mar 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with urethral discontinuity, urethral stricture, or inability to use a three lumen catheter normally affect perfusion therapy.
- Patients who had undergone partial cystectomy or abnormal bladder structure were judged by the investigator to be unsuitable for perfusion therapy.
- Recurrent patients with a prior history of BCG or bladder thermoperfusion therapy.
- Participated in other clinical trials 1 month before the trial.
Other illness
- Patients with bladder cancer in situ.
- The patients were complicated with bladder perforation, gross hematuria or urinary tract infection of grade 3-4.
- A history of allergy to injected drugs (gemcitabine).
- History of pelvic radiation, systemic chemotherapy, or immunotherapy.
- Complicated with cardiovascular, cerebrovascular, hematopoietic, immune system and other serious diseases.
- Patients with mental illness, substance abuse, alcoholism, and inability to cooperate.
Other
- Combined with proven upper urinary tract or urethral tumors.
- Patients with severe coagulation dysfunction.
- Breastfeeding, pregnant, or planning to have a baby in the near future.
- Vesicoureteral regurgitation.
- The investigator considered it inappropriate to participate in this clinical trial.
Who the study is looking for
- 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).
- 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).
- KPS score ≥80, expected survival \> 30 months.
- Pathological suggested non-myoinvasive urothelial carcinoma of the bladder.
- Age between 18 and 70 years, all genders.
- Volunteer to participate in this clinical trial and written informed consent.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.