Hepatocellular CarcinomaPhase 3NCT01966133
TACE as an Adjuvant Therapy After Hepatectomy for HCC
A Phase 3 study testing Ethiodized Oil + Doxorubicin in people with Hepatocellular Carcinoma, run by Jia Fan at 1 site in China.
Trial summary
Investigators 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 of patients with high risk factors for residual tumor. 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?
- Ethiodized Oil + Doxorubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- Aug 2011to Aug 2017
- Phase
- Phase 3
- 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
- Tumors with a diameter more than 5 cm, multiple nodules, or microvascular invasion were defined as high risk factors for residual tumor and used for patient stratification.
- 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
- Impaired liver function with either clinically detected ascites, hepatic encephalopathy, serum albumin < 25g/L or bilirubin > 50micromol/L
- Renal impairment with creatinine > 200micromol/L
Show all 12Show fewer
- Severe concurrent medical illness persisting > 6 weeks after hepatectomy
- History of other cancer
- Hepatic artery anomaly making TACE not possible
- Allergy to doxorubicin 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
Investigators 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 of patients with high risk factors for residual tumor. The aim of this study is to compare the survival of patients with high risk factors for residual tumor 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, especially for the patients with high risk factors for residual tumor, such as tumors with a diameter more than 5 cm, multiple nodules, and microvascular invasion. 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. The main complications of TACE are liver function damage, mild feverish symptoms, vomit , etc. But most of them are reversible.
We conduct a randomised controlled trial evaluating the efficacy of using TACE after hepatectomy in HCC patients with high risk factors for residual tumor (tumors with a diameter more than 5 cm, multiple nodules, or microvascular invasion).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Ethiodized Oil + Doxorubicin
- Keywords
- HCC, Randomised controlled trial, TACE, Resection
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethiodized Oil + DoxorubicinDrug
Also called doxorubicin-lipiodol mixture
TACE using doxorubicin-lipiodol mixture
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | no interventions were assigned |
| TACE('Ethiodized Oil + Doxorubicin) | Active comparator | TACE using Ethiodized Oil + Doxorubicin mixture was infused through catheter placed at hepatic artery followed by gelfoam embolisation. This is performed 4-6 weeks after surgery. Receives: Drug: Ethiodized Oil + Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Measured: 3 years after operation
Secondary outcomes (2)
Overall Survival
Measured: 3-year after surgery
Complications of transarterial chemoembolisation
Measured: 3-month after transarterial chemoembolisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2013 (estimated)
- Study startAug 2011
- Primary completionAug 2016
- Study completionAug 2017 (estimated)
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.
- 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
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jia Fan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jia Fan, Fudan University
- Investigators
- Jia Fan, MD, Principal investigator, Liver cancer institute, Fudan universityJian Zhou, MD, Study director, Liver Cancer Institute, Zhong Shan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966133
- Sponsor's protocol ID
- LCI-125-009
- Status last verified
- Jan 2017
- First submitted
- 16 Oct 2013
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. 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
- NCT01966133
- Acronym / sponsor ID
- LCI-125-009
- Conditions
- Hepatocellular Carcinoma
- Keywords
- HCC, Randomised controlled trial, TACE, Resection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Jia FanUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2017 (estimated)
- First posted
- 21 Oct 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.
Investigators 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 of patients with high risk factors for residual tumor. The aim of this study is to compare the survival of patients with high risk factors for residual tumor 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, especially for the patients with high risk factors for residual tumor, such as tumors with a diameter more than 5 cm, multiple nodules, and microvascular invasion. 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. The main complications of TACE are liver function damage, mild feverish symptoms, vomit , etc. But most of them are reversible.
We conduct a randomised controlled trial evaluating the efficacy of using TACE after hepatectomy in HCC patients with high risk factors for residual tumor (tumors with a diameter more than 5 cm, multiple nodules, or microvascular invasion).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –no interventions were assigned |
| TACE('Ethiodized Oil + Doxorubicin) | Active comparator | Drug: Ethiodized Oil + DoxorubicinTACE using Ethiodized Oil + Doxorubicin mixture was infused through catheter placed at hepatic artery followed by gelfoam embolisation. This is performed 4-6 weeks after surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HCC patients received curative hepatectomy with negative resection margin
- Tumors with a diameter more than 5 cm, multiple nodules, or microvascular invasion were defined as high risk factors for residual tumor and used for patient stratification.
- Age from 18 to 70
- Child-Pugh class A
- ASA class I to III
Key exclusion criteria (12 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
- Impaired liver function with either clinically detected ascites, hepatic encephalopathy, serum albumin < 25g/L or bilirubin > 50micromol/L
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 |
|---|---|---|
| Ethiodized Oil + DoxorubicinAlso: doxorubicin-lipiodol mixtureTACE using doxorubicin-lipiodol mixture | Drug | TACE('Ethiodized Oil + Doxorubicin) |
Primary outcome
Disease-free survival
Time frame: 3 years after operation
2 secondary outcomes
Overall Survival
Time frame: 3-year after surgery
Complications of transarterial chemoembolisation
Time frame: 3-month after transarterial chemoembolisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
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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.
Jia Fan, MD principal investigator
Liver cancer institute, Fudan university
Jian Zhou, MD study director
Liver Cancer Institute, Zhong Shan Hospital, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ethiodized Oil + Doxorubicin in people with Hepatocellular Carcinoma, run by Jia Fan 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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 9 Jan 2017. 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.
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?
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?
Disease-free survival (time frame: 3 years after operation). 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 9 Jan 2017.