Hepatocellular CarcinomaNCT01817205
Combined Chemoembolization and Systemic Hyperthermia for Unresectable Hepatocellular Carcinoma
A study testing TACE with Hyperthermia Treatment in people with Hepatocellular Carcinoma, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial summary
The objective is to evaluate the safety and therapeutic effect of combined hyperthermia and TACE for unresectable HCC Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- TACE with Hyperthermia Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesHong Kong
- Study dates
- Mar 2013to Nov 2016
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient factor
- Age between 18 and 75
- Child-Pugh A cirrhosis
- Eastern Cooperative Oncology Group(ECOG) performance status Grade 2 or below
- No serious concurrent medical illness
- Prior treatment for HCC including surgery, local ablation, or transarterial treatments allowed
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- Imaging evidence of poor intralesional treatment response or disease progression despite transarterial treatment
- Platelet count ≥ 50 10^9/L
- Tumor factor
- HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology
- Unresectable and locally advanced disease without extra-hepatic disease
- Hypervascular lesions on CT
- Greatest dimension of the largest tumor ≤15cm
Who cannot join
- Patient factor
- History of significant concurrent medical illness such as ischemic heart disease or heart failure
- Metallic body implants, not including dental fillings
- Serum creatinine level > 130 umol/L
- Presence of biliary obstruction not amenable to drainage
- Child-Pugh B or C cirrhosis
Show all 40Show fewer
- Unable to give consent
- Evidence of impaired liver function
- History of hepatic encephalopathy
- Intractable ascites not controllable by medical therapy
- History of variceal bleeding within last 3 months
- Serum total bilirubin level >25 umol/L for the first 5 patients, serum total bilirubin level >35 umol/L for the second 5 patients
- Serum albumin level < 30g/L
- International normalized ratio(INR) >1.3
- Tumor factor
- Presence of extrahepatic metastasis
- Infiltrative lesion
- Vascular invasion
- Hepatic artery thrombosis
- Partial or complete thrombosis of the main portal vein
- Tumor invasion of portal branch of contralateral lobe
- Hepatic vein tumor thrombus
- Significant arterioportal shunt
- Significant arteriovenous shunt
- Contraindication for hyperthermia
- Known brain metastasis
- Recent stroke or cerebral hemorrhage within last 6 months
- Poorly controlled epilepsy
- Poorly controlled cardiac arrhythmias
- Myocardial infarction within last 6 months
- Unstable angina within last 6 months
- Poorly controlled hypertension
- Poorly controlled diabetes
- History of malignant hyperthermia
- Photodermatosis
- Pregnancy
- Lactation
- Serious infection
- Grade 3 or above adverse event in serological total bilirubin or albumin according to Version 4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events
- Elevation of serum alanine transaminase ≥ 10 times upper limit of normal
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
About this study
Official title: A Pilot Study on the Feasibility of Combined Chemoembolization and Adjuvant Systemic Hyperthermia for Palliative Treatment of Unresectable Hepatocellular Carcinoma(HCC)
The objective is to evaluate the safety and therapeutic effect of combined hyperthermia and TACE for unresectable HCC
Read the detailed description
Most patients with Hepatocellular carcinoma (HCC) are diagnosed at an intermediate and advanced stage when the tumors become unresectable. Transcatheter arterial chemoembolization (TACE) has been shown to be effective in prolongation of survival for patients with unresectable HCC and generally adopted as a standard palliative treatment option for patients with intermediate stage HCC. However, the therapeutic effect of TACE in terms of objective tumor response is variable and modest (27%-40%), indicating that there is actually much room for improvement in the treatment. In many cases, patients with intrahepatic HCC uncontrolled after TACE treatment may not be suitable for other treatment options because of their physical condition. For these patients, repeat TACE combined with adjuvant systemic hyperthermia may offer a chance of disease control.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- TACE with Hyperthermia Treatment
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE with Hyperthermia TreatmentProcedure or surgery
Transcatheter arterial chemoembolization (TACE) is performed under local anesthesia with right femoral puncture. The feeding lobar hepatic artery is selectively catheterized for drug delivery.
Systemic hyperthermia is induced with an external energy source using microwave electromagnetic energy, with the patient lying supine on the treatment bed of the hyperthermia equipment, exposing the abdomen to the microwave transmitter.
| Study group | Role | What they receive |
|---|---|---|
| TACE with Hyperthermia treatment | Other | Interventions: TACE to all liver lesions and two sessions of systemic hyperthermia performed at 24 hours and 48 hours respectively after TACE. Receives: Procedure: TACE with Hyperthermia Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose limiting toxicity
Measured: 30 days from the study treatment
Secondary outcomes (3)
adverse event of treatment
Measured: within 6 months of treatment
imaging evidence of objective tumor response
Measured: 3 and 6 months after treatment
treatment response by alphafetoprotein
Measured: 6 months after 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 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: poor case accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong
- Responsible party
- Principal investigator, Simon Yu, Chinese University of Hong Kong
- Investigators
- Simon CH Yu, MD, FRCR, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817205
- Sponsor's protocol ID
- VIR-13-01
- Status last verified
- Dec 2016
- First submitted
- 21 Mar 2013
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Feasibility of Combined Chemoembolization and Adjuvant Systemic Hyperthermia for Palliative Treatment of Unresectable Hepatocellular Carcinoma(HCC)
- ClinicalTrials.gov ID
- NCT01817205
- Acronym / sponsor ID
- VIR-13-01
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor case accrual
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong
- Study start
- Mar 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 25 Mar 2013 (estimated)
- 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 objective is to evaluate the safety and therapeutic effect of combined hyperthermia and TACE for unresectable HCC
Detailed description
Most patients with Hepatocellular carcinoma (HCC) are diagnosed at an intermediate and advanced stage when the tumors become unresectable. Transcatheter arterial chemoembolization (TACE) has been shown to be effective in prolongation of survival for patients with unresectable HCC and generally adopted as a standard palliative treatment option for patients with intermediate stage HCC. However, the therapeutic effect of TACE in terms of objective tumor response is variable and modest (27%-40%), indicating that there is actually much room for improvement in the treatment. In many cases, patients with intrahepatic HCC uncontrolled after TACE treatment may not be suitable for other treatment options because of their physical condition. For these patients, repeat TACE combined with adjuvant systemic hyperthermia may offer a chance of disease control.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TACE with Hyperthermia treatment | Other | Procedure: TACE with Hyperthermia TreatmentInterventions: TACE to all liver lesions and two sessions of systemic hyperthermia performed at 24 hours and 48 hours respectively after TACE. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient factor
- Age between 18 and 75
- Child-Pugh A cirrhosis
- Eastern Cooperative Oncology Group(ECOG) performance status Grade 2 or below
- No serious concurrent medical illness
Key exclusion criteria (40 listed)
- Patient factor
- History of significant concurrent medical illness such as ischemic heart disease or heart failure
- Metallic body implants, not including dental fillings
- Serum creatinine level > 130 umol/L
- Presence of biliary obstruction not amenable to drainage
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 |
|---|---|---|
| TACE with Hyperthermia TreatmentTranscatheter arterial chemoembolization (TACE) is performed under local anesthesia with right femoral puncture. The feeding lobar hepatic artery is selectively catheterized for drug delivery. Systemic hyperthermia is induced with an external energy source using microwave electromagnetic energy, with the patient lying supine on the treatment bed of the hyperthermia equipment, exposing the abdomen to the microwave transmitter. | Procedure or surgery | TACE with Hyperthermia treatment |
Primary outcome
dose limiting toxicity
Time frame: 30 days from the study treatment
3 secondary outcomes
adverse event of treatment
Time frame: within 6 months of treatment
imaging evidence of objective tumor response
Time frame: 3 and 6 months after treatment
treatment response by alphafetoprotein
Time frame: 6 months after treatment
Results and safety
The study was stopped early (reason given: poor case accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- 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.
Simon CH Yu, MD, FRCR principal investigator
Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TACE with Hyperthermia Treatment in people with Hepatocellular Carcinoma, run by Chinese University of Hong Kong at 2 sites 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 13 inclusion and 40 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: stopped early, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: poor case accrual). Results are not available in the source record.
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?
dose limiting toxicity (time frame: 30 days from the study treatment). 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 30 Aug 2019.