Hepatocellular CarcinomaA-TECHNCT01512407
RCT on Adjuvant TACE After Hepatectomy for HCC
A study testing Transarterial chemoembolisation using cisplatin-lipiodol mixture in people with Hepatocellular Carcinoma, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
We hypothesise that the use of transarterial chemoembolisation (TACE) after liver resection in patients with hepatocellular carcinoma can eradicate residual cancer cells in the liver and thus improve survival. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Transarterial chemoembolisation using cisplatin-lipiodol mixture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- Nov 2011to Dec 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HCC patients received curative hepatectomy with negative resection margin
- Age from 18 to 70
- Child-Pugh class A
- ASA class I to III
- ECOG performance status Grade 0 or 1
Who cannot join
- Patients receiving concomitant local ablation or previous TACE
- Main portal vein tumour thrombus extraction during hepatectomy
- Tumour arising from caudate lobe
- Presence of extra-hepatic disease
- Very early HCC with solitary tumour and size < 2cm
- Impaired liver function with either clinically detected ascites, hepatic encephalopathy, serum albumin < 25g/L or bilirubin > 50micromol/L
Show all 13Show fewer
- Renal impairment with creatinine > 200micromol/L
- Severe concurrent medical illness persisting > 6 weeks after hepatectomy
- History of other cancer
- Hepatic artery anomaly making TACE not possible
- Allergy to cisplatin or lipiodol
- Pregnant woman
- Informed consent not available
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Trial on Adjuvant Transarterial Chemoembolisation After Curative Hepatectomy for Hepatocellular Carcinoma
We hypothesise that the use of transarterial chemoembolisation (TACE) after liver resection in patients with hepatocellular carcinoma can eradicate residual cancer cells in the liver and thus improve survival. The aim of this study is to compare the survival of patients undergoing liver resection plus post-operative TACE versus liver resection alone.
Read the detailed description
Liver resection is the mainstay of curative treatment for hepatocellular carcinoma (HCC). However, recurrence is common after surgery and most occurs in the liver. Transarterial chemoembolisation (TACE) is an effective palliative treatment for HCC. It involves the infusion of chemotherapeutic agent admixed with iodised oil followed by embolisation of the hepatic arterial flow using small particles. This procedures allows application of smaller dose of chemotherapy concentrated to the liver and thus is well tolerated with minimal side effects. We conduct a randomised controlled trial evaluating the efficacy of using TACE after hepatectomy in HCC patients.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Transarterial chemoembolisation using cisplatin-lipiodol mixture
- Keywords
- Hepatocellular Carcinoma, Randomised controlled trial, Transarterial chemoembolisation
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial chemoembolisation using cisplatin-lipiodol mixtureProcedure or surgery
Cisplatin-lipiodol mixture was infused through catheter placed at hepatic artery followed by gelfoam embolisation. This is performed 4 to 6 weeks after surgery
| Study group | Role | What they receive |
|---|---|---|
| Hepatectomy plus TACE | Experimental | Transarterial chemoembolisation will be performed 4 to 6 weeks after hepatectomy Receives: Procedure: Transarterial chemoembolisation using cisplatin-lipiodol mixture |
| Hepatectomy alone | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year recurrence rate
The 1-year recurrence rate after hepatectomy in both arms of study were compared
Measured: 1-year after hepatectomy
Secondary outcomes (4)
Disease-free survival
Measured: 5 years after operation
Overall Survival
Measured: 5-year after surgery
Complications of transarterial chemoembolisation
Measured: 3-month after transarterial chemoembolisation
Health-related quality of life assessment
The quality of life assessment was measured by Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire (Chinese version 3)
Measured: 1-year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionMay 2019
- Study completionDec 2019
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheung Yue Sun, Chinese University of Hong Kong
- Investigators
- Yue Sun Cheung, MBChB, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512407
- Sponsor's protocol ID
- CRE-2011.236-T
- Acronym
- A-TECH
- Status last verified
- Mar 2022
- First submitted
- 14 Jan 2012
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial on Adjuvant Transarterial Chemoembolisation After Curative Hepatectomy for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01512407
- Acronym / sponsor ID
- A-TECH / CRE-2011.236-T
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Randomised controlled trial, Transarterial chemoembolisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Nov 2011 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 19 Jan 2012 (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.
We hypothesise that the use of transarterial chemoembolisation (TACE) after liver resection in patients with hepatocellular carcinoma can eradicate residual cancer cells in the liver and thus improve survival. The aim of this study is to compare the survival of patients undergoing liver resection plus post-operative TACE versus liver resection alone.
Detailed description
Liver resection is the mainstay of curative treatment for hepatocellular carcinoma (HCC). However, recurrence is common after surgery and most occurs in the liver. Transarterial chemoembolisation (TACE) is an effective palliative treatment for HCC. It involves the infusion of chemotherapeutic agent admixed with iodised oil followed by embolisation of the hepatic arterial flow using small particles. This procedures allows application of smaller dose of chemotherapy concentrated to the liver and thus is well tolerated with minimal side effects. We conduct a randomised controlled trial evaluating the efficacy of using TACE after hepatectomy in HCC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hepatectomy plus TACE | Experimental | Procedure: Transarterial chemoembolisation using cisplatin-lipiodol mixtureTransarterial chemoembolisation will be performed 4 to 6 weeks after hepatectomy |
| Hepatectomy alone | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HCC patients received curative hepatectomy with negative resection margin
- Age from 18 to 70
- Child-Pugh class A
- ASA class I to III
- ECOG performance status Grade 0 or 1
Key exclusion criteria (13 listed)
- Patients receiving concomitant local ablation or previous TACE
- Main portal vein tumour thrombus extraction during hepatectomy
- Tumour arising from caudate lobe
- Presence of extra-hepatic disease
- Very early HCC with solitary tumour and size < 2cm
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 |
|---|---|---|
| Transarterial chemoembolisation using cisplatin-lipiodol mixtureCisplatin-lipiodol mixture was infused through catheter placed at hepatic artery followed by gelfoam embolisation. This is performed 4 to 6 weeks after surgery | Procedure or surgery | Hepatectomy plus TACE |
Primary outcome
1-year recurrence rate
Time frame: 1-year after hepatectomy
The 1-year recurrence rate after hepatectomy in both arms of study were compared
4 secondary outcomes
Disease-free survival
Time frame: 5 years after operation
Overall Survival
Time frame: 5-year after surgery
Complications of transarterial chemoembolisation
Time frame: 3-month after transarterial chemoembolisation
Health-related quality of life assessment
Time frame: 1-year after surgery
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 18 Mar 2022.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
Yue Sun Cheung, MBChB principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transarterial chemoembolisation using cisplatin-lipiodol mixture in people with Hepatocellular Carcinoma, run by Chinese University of Hong Kong at 1 site in China.
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 5 inclusion and 13 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 18 Mar 2022. 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 China. 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?
1-year recurrence rate (time frame: 1-year after hepatectomy). 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 18 Mar 2022.