Non-Muscle-Invasive Bladder CancerPhase 3NCT06327932
HIVEC in Patients With Non-Muscle-Invasive Bladder Cancer
A Phase 3 study testing TURBT, HIVEC and Intravesical Chemotherapy in people with Non-Muscle-Invasive Bladder Cancer, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-Muscle-Invasive Bladder Cancer
- What is being tested?
- TURBT, HIVEC and Intravesical Chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 31 Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with bladder cancer in situ.
- Combined with proven upper urinary tract or urethral tumors.
- The patients were complicated with bladder perforation, gross hematuria or urinary tract infection of grade 3-4.
- 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.
- Patients with severe coagulation dysfunction.
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- 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.
- Breastfeeding, pregnant, or planning to have a baby in the near future.
- Recurrent patients with a prior history of BCG or bladder thermoperfusion therapy.
- Participated in other clinical trials 1 month before the trial.
- Vesicoureteral regurgitation.
- The investigator considered it inappropriate to participate in this clinical trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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).
Read the 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.
- Conditions
- Non-Muscle-Invasive Bladder Cancer
- Being tested
- TURBT, HIVEC, Intravesical Chemotherapy, Gemcitabine
- Keywords
- Non-Muscle-Invasive Bladder Cancer, Hyperthermic Intravesical Chemotherapy, recurrence rate
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TURBTProcedure or surgery
Transurethral Resection of Bladder Tumors
HIVECProcedure or surgery
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.
Intravesical ChemotherapyProcedure or surgery
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.
GemcitabineDrug
Gemcitabine (3g/150ml NS).
| Study group | Role | What they receive |
|---|---|---|
| Matched control | Active comparator | Patients undergo Transurethral Resection of Bladder Tumors (TURBT) and receive Intravesical Chemotherapy. Receives: Procedure: TURBT; Procedure: Intravesical Chemotherapy; Drug: Gemcitabine |
| HIVEC | Experimental | Patients undergo Transurethral Resection of Bladder Tumors (TURBT) and Hyperthermic Intravesical Chemotherapy (HIVEC) Receives: Procedure: TURBT; Procedure: HIVEC; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
The patients were observed for 2 years since they received HIVEC or intravesical chemotherapy，and cystoscopy was repeated every 3 months. If a new tumor-like organism is seen under the microscope, and pathology indicates urothelial carcinoma of the bladder after TURBT or cystoscopic biopsy, the tumor is considered to have recurred. 2-year recurrence rate = number of recurrence cases within 2 years / total number of enrolled cases * 100%.
Measured: 2-year
Secondary outcomes (6)
1-year recurrence rate
1-year recurrence rate = number of recurrence cases within 1 years / total number of enrolled cases * 100%.
Measured: 1-year
Recurrence-free survival (RFS) rate
Recurrence free survival is calculated from the date of randomization to the date of record recurrence or death from any cause, whichever occurred first.
Measured: 2-year
Time to treatment failure
Time to treatment failure is calculated from the date of randomization to the date of treatment discontinuation/termination, including any reason for discontinuation/termination, such as disease progression, death, withdrawal due to adverse events, subject's refusal to continue the study, or use of a new treatment.
Measured: 2-year
Success rate of therapeutic operation
Success rate of therapeutic operation
Measured: 2-year
Quality of international prostate symptom score
IPSS is International Prostate Symptom Score (IPSS), 0~35, the higher the score, the worse the symptom severity is.
Measured: Evaluation was performed during the screening period and at 3, 12 and 24 months after initiation of treatment.
Quality of bother of score
BS is Bother of Score (BS), 0~6, the higher the score, the worse the performance is.BS is the Bother of Score (BS), 0~6, the higher the score, the worse the performance is.
Measured: Evaluation was performed during the screening period and at 3, 12 and 24 months after initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Muscle-Invasive Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuzhong Cui, MD, Principal investigator, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327932
- Sponsor's protocol ID
- HIVEC(PRG)
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06327932
- Acronym / sponsor ID
- HIVEC(PRG)
- Conditions
- Non-Muscle-Invasive Bladder Cancer
- Keywords
- Non-Muscle-Invasive Bladder Cancer, Hyperthermic Intravesical Chemotherapy, recurrence rate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Matched control | Active comparator | Procedure: TURBT, Procedure: Intravesical Chemotherapy, Drug: GemcitabinePatients undergo Transurethral Resection of Bladder Tumors (TURBT) and receive Intravesical Chemotherapy. |
| HIVEC | Experimental | Procedure: TURBT, Procedure: HIVEC, Drug: GemcitabinePatients undergo Transurethral Resection of Bladder Tumors (TURBT) and Hyperthermic Intravesical Chemotherapy (HIVEC) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- Patients with bladder cancer in situ.
- Combined with proven upper urinary tract or urethral tumors.
- The patients were complicated with bladder perforation, gross hematuria or urinary tract infection of grade 3-4.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TURBTTransurethral Resection of Bladder Tumors | Procedure or surgery | HIVEC, Matched control |
| HIVECHyperthermic 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 or surgery | HIVEC |
| Intravesical ChemotherapyIntravesical 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. | Procedure or surgery | Matched control |
| GemcitabineGemcitabine (3g/150ml NS). | Drug | HIVEC, Matched control |
Primary outcome
Recurrence rate
Time frame: 2-year
The patients were observed for 2 years since they received HIVEC or intravesical chemotherapy，and cystoscopy was repeated every 3 months. If a new tumor-like organism is seen under the microscope, and pathology indicates urothelial carcinoma of the bladder after TURBT or cystoscopic biopsy, the tumor is considered to have recurred. 2-year recurrence rate = number of recurrence cases within 2 years / total number of enrolled cases * 100%.
6 secondary outcomes
1-year recurrence rate
Time frame: 1-year
Recurrence-free survival (RFS) rate
Time frame: 2-year
Time to treatment failure
Time frame: 2-year
Success rate of therapeutic operation
Time frame: 2-year
Quality of international prostate symptom score
Time frame: Evaluation was performed during the screening period and at 3, 12 and 24 months after initiation of treatment.
Quality of bother of score
Time frame: Evaluation was performed during the screening period and at 3, 12 and 24 months after initiation of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shuzhong Cui, MD principal investigator
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TURBT, HIVEC and Intravesical Chemotherapy in people with Non-Muscle-Invasive Bladder Cancer, run by Affiliated Cancer Hospital & Institute of Guangzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuzhong Cui, MD (020-66673666, cuishuzhong@gzhmu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: 2-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.