Bladder CancerI-HIVECNCT03689478
Use of Immediate Hyperthermic Intravesical Chemotherapy Following TURBT
A study testing Hyperthermic intravesical chemotherapy in people with Bladder Cancer and Hyperthermia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a prospective single-arm pilot study investigating the safety and feasibility of giving hyperthermic intravesical chemotherapy immediately following transurethral resection of bladder tumour. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Hyperthermia, Chemotherapy Effect
- What is being tested?
- Hyperthermic intravesical chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 22 Oct 2018to 7 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or above with informed consent
Who cannot join
- ECOG performance status ≥2
- ASA 4 or above
- History of bleeding disorder
- Any use of anti-coagulants
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study on the Use of Immediate Hyperthermic Intravesical Chemotherapy Following Transurethral Resection of Bladder Tumour (I-HIVEC Study)
This is a prospective single-arm pilot study investigating the safety and feasibility of giving hyperthermic intravesical chemotherapy immediately following transurethral resection of bladder tumour.
Read the detailed description
The Combat Bladder Recirculation System (BRS) is a CE marked device which has been used in over 200 sites in Europe. It is an aluminum heat exchanger that allows hyperthermic intravesical chemotherapy (HIVEC) at 43±0.2 degrees for patients with bladder cancer. Previous studies showed that the Combat BRS could warm the entire bladder wall to the target temperature with excellent safety parameters. The flow rates and pressure levels are kept low during the HIVEC treatment. A previous study has demonstrated the safety and tolerability of HIVEC as a maintenance therapy for patients with non-muscle-invasive bladder cancer (NMIBC), and two randomized controlled trials are underway to demonstrate its efficacy in terms of disease recurrence and progression. On the other hand, the use of HIVEC immediately following transurethral resection of bladder tumour (TURBT) remains largely unexplored. It is the investigators' current practice to give intravesical mitomycin C (MMC) to all patients who have endoscopically NMIBC with complete resection, provided that there are no bladder perforations being noted. In this study, the investigators shall evaluate the safety and feasibility of hyperthermia in addition to the current practice of intravesical MMC alone immediately following TURBT.
- Conditions
- Bladder Cancer, Hyperthermia, Chemotherapy Effect
- Being tested
- Hyperthermic intravesical chemotherapy
- Keywords
- Hyperthermic intravesical chemotherapy, Bladder cancer
- Medical subject headings
- Urinary Bladder Neoplasms, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperthermic intravesical chemotherapyOther
Intravesical instillation of 40mg mitomycin C at 43 degrees for 60 minutes immediately after transurethral resection of bladder tumour
| Study group | Role | What they receive |
|---|---|---|
| Hyperthermic intravesical chemotherapy | Experimental | Intravesical instillation of 40mg mitomycin C at 43 degrees for 60 minutes immediately after transurethral resection of bladder tumour Receives: Other: Hyperthermic intravesical chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day complications
Complications which occur within 30 days after the experimental treatment
Measured: Thirty days after the experimental treatment
Secondary outcomes (5)
Hyperthermic intravesical chemotherapy instillation rate
Rate of hyperthermic intravesical chemotherapy instillation given after the operation
Measured: One day after surgery
Duration of urethral catheterisation
Duration of urethral catheterisation after the experimental treatment
Measured: Two days after the experimental treatment
Rate of bladder irrigation
Rate of bladder irrigation given after the experimental treatment
Measured: One day after the experimental treatment
Duration of bladder irrigation
Duration of bladder irrigation after the experimental treatment
Measured: Two days after the experimental treatment
Hospital stay
Duration of hospital stay for the experimental treatment
Measured: Three days after the experimental treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start22 Oct 2018
- Primary completion31 Aug 2021
- Study completion7 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective single-arm study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Yuen Chun TEOH, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689478
- Sponsor's protocol ID
- CRE Ref. No. 2018.206
- Acronym
- I-HIVEC
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2018
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sylvester RJ, van der Meijden AP, Oosterlinck W, Witjes JA, Bouffioux C, Denis L, Newling DW, Kurth K. Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol. 2006 Mar;49(3):466-5; discussion 475-7. doi: 10.1016/j.eururo.2005.12.031. Epub 2006 Jan 17.
PubMed 16442208Babjuk M, Bohle A, Burger M, Capoun O, Cohen D, Comperat EM, Hernandez V, Kaasinen E, Palou J, Roupret M, van Rhijn BWG, Shariat SF, Soukup V, Sylvester RJ, Zigeuner R. EAU Guidelines on Non-Muscle-invasive Urothelial Carcinoma of the Bladder: Update 2016. Eur Urol. 2017 Mar;71(3):447-461. doi: 10.1016/j.eururo.2016.05.041. Epub 2016 Jun 17.
PubMed 27324428Schooneveldt G, Bakker A, Balidemaj E, Chopra R, Crezee J, Geijsen ED, Hartmann J, Hulshof MC, Kok HP, Paulides MM, Sousa-Escandon A, Stauffer PR, Maccarini PF. Thermal dosimetry for bladder hyperthermia treatment. An overview. Int J Hyperthermia. 2016 Jun;32(4):417-33. doi: 10.3109/02656736.2016.1156170. Epub 2016 May 1.
PubMed 27132465Owusu RA, Abern MR, Inman BA. Hyperthermia as adjunct to intravesical chemotherapy for bladder cancer. Biomed Res Int. 2013;2013:262313. doi: 10.1155/2013/262313. Epub 2013 Sep 1.
PubMed 24073396Kok HP, Wust P, Stauffer PR, Bardati F, van Rhoon GC, Crezee J. Current state of the art of regional hyperthermia treatment planning: a review. Radiat Oncol. 2015 Sep 17;10:196. doi: 10.1186/s13014-015-0503-8.
PubMed 26383087Teicher BA, Kowal CD, Kennedy KA, Sartorelli AC. Enhancement by hyperthermia of the in vitro cytotoxicity of mitomycin C toward hypoxic tumor cells. Cancer Res. 1981 Mar;41(3):1096-9.
PubMed 7459853
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Use of Immediate Hyperthermic Intravesical Chemotherapy Following Transurethral Resection of Bladder Tumour (I-HIVEC Study)
- ClinicalTrials.gov ID
- NCT03689478
- Acronym / sponsor ID
- I-HIVEC / CRE Ref. No. 2018.206
- Conditions
- Bladder Cancer, Hyperthermia, Chemotherapy Effect
- Keywords
- Hyperthermic intravesical chemotherapy, Bladder cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 28 Sep 2018 (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.
This is a prospective single-arm pilot study investigating the safety and feasibility of giving hyperthermic intravesical chemotherapy immediately following transurethral resection of bladder tumour.
Detailed description
The Combat Bladder Recirculation System (BRS) is a CE marked device which has been used in over 200 sites in Europe. It is an aluminum heat exchanger that allows hyperthermic intravesical chemotherapy (HIVEC) at 43±0.2 degrees for patients with bladder cancer. Previous studies showed that the Combat BRS could warm the entire bladder wall to the target temperature with excellent safety parameters. The flow rates and pressure levels are kept low during the HIVEC treatment. A previous study has demonstrated the safety and tolerability of HIVEC as a maintenance therapy for patients with non-muscle-invasive bladder cancer (NMIBC), and two randomized controlled trials are underway to demonstrate its efficacy in terms of disease recurrence and progression. On the other hand, the use of HIVEC immediately following transurethral resection of bladder tumour (TURBT) remains largely unexplored. It is the investigators' current practice to give intravesical mitomycin C (MMC) to all patients who have endoscopically NMIBC with complete resection, provided that there are no bladder perforations being noted. In this study, the investigators shall evaluate the safety and feasibility of hyperthermia in addition to the current practice of intravesical MMC alone immediately following TURBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single-arm study
| Arm | Type | Receives |
|---|---|---|
| Hyperthermic intravesical chemotherapy | Experimental | Other: Hyperthermic intravesical chemotherapyIntravesical instillation of 40mg mitomycin C at 43 degrees for 60 minutes immediately after transurethral resection of bladder tumour |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years or above with informed consent
Key exclusion criteria (5 listed)
- ECOG performance status ≥2
- ASA 4 or above
- History of bleeding disorder
- Any use of anti-coagulants
- Pregnancy
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 |
|---|---|---|
| Hyperthermic intravesical chemotherapyIntravesical instillation of 40mg mitomycin C at 43 degrees for 60 minutes immediately after transurethral resection of bladder tumour | Other | Hyperthermic intravesical chemotherapy |
Primary outcome
30-day complications
Time frame: Thirty days after the experimental treatment
Complications which occur within 30 days after the experimental treatment
5 secondary outcomes
Hyperthermic intravesical chemotherapy instillation rate
Time frame: One day after surgery
Duration of urethral catheterisation
Time frame: Two days after the experimental treatment
Rate of bladder irrigation
Time frame: One day after the experimental treatment
Duration of bladder irrigation
Time frame: Two days after the experimental treatment
Hospital stay
Time frame: Three days after the experimental treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 16442208Sylvester RJ, van der Meijden AP, Oosterlinck W, Witjes JA, Bouffioux C, Denis L, Newling DW, Kurth K. Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol. 2006 Mar;49(3):466-5; discussion 475-7. doi: 10.1016/j.eururo.2005.12.031. Epub 2006 Jan 17.
- Background: PubMed 27324428Babjuk M, Bohle A, Burger M, Capoun O, Cohen D, Comperat EM, Hernandez V, Kaasinen E, Palou J, Roupret M, van Rhijn BWG, Shariat SF, Soukup V, Sylvester RJ, Zigeuner R. EAU Guidelines on Non-Muscle-invasive Urothelial Carcinoma of the Bladder: Update 2016. Eur Urol. 2017 Mar;71(3):447-461. doi: 10.1016/j.eururo.2016.05.041. Epub 2016 Jun 17.
- Background: PubMed 27132465Schooneveldt G, Bakker A, Balidemaj E, Chopra R, Crezee J, Geijsen ED, Hartmann J, Hulshof MC, Kok HP, Paulides MM, Sousa-Escandon A, Stauffer PR, Maccarini PF. Thermal dosimetry for bladder hyperthermia treatment. An overview. Int J Hyperthermia. 2016 Jun;32(4):417-33. doi: 10.3109/02656736.2016.1156170. Epub 2016 May 1.
- Background: PubMed 24073396Owusu RA, Abern MR, Inman BA. Hyperthermia as adjunct to intravesical chemotherapy for bladder cancer. Biomed Res Int. 2013;2013:262313. doi: 10.1155/2013/262313. Epub 2013 Sep 1.
- Background: PubMed 26383087Kok HP, Wust P, Stauffer PR, Bardati F, van Rhoon GC, Crezee J. Current state of the art of regional hyperthermia treatment planning: a review. Radiat Oncol. 2015 Sep 17;10:196. doi: 10.1186/s13014-015-0503-8.
- Background: PubMed 7459853Teicher BA, Kowal CD, Kennedy KA, Sartorelli AC. Enhancement by hyperthermia of the in vitro cytotoxicity of mitomycin C toward hypoxic tumor cells. Cancer Res. 1981 Mar;41(3):1096-9.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperthermic intravesical chemotherapy in people with Bladder Cancer and Hyperthermia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day complications (time frame: Thirty days after the experimental treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03689478, which also lists 6 linked publications.
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 27 Oct 2026.