Hepatocellular Carcinoma by BCLC StageNCT03652896
Anatomy-based Resection or Margin-based Resection for Hepatocellular Carcinoma
A study testing anatomical liver resection in people with Hepatocellular Carcinoma by BCLC Stage, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Anatomical liver resection was widely accepted as first line curative therapy for hepatocellular carcinoma. However, number of retrospective clinical studies showed no priority of anatomical resection for hepatocellular, compared with non-anatomical resection. Read more about this study
- Who is it for?
- Ages 17 to 65 years
- Conditions the study is for
- Hepatocellular Carcinoma by BCLC Stage
- What is being tested?
- anatomical liver resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 30 Dec 2023
- 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 17 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients diagnosed with hepatocellular carcinoma of BCLC stage A
- liver function Child-pugh A
- normal indocyanine green retention rate
- adequate liver remnant
Who cannot join
- age less than 17 y or older than 65 y
- unresectable liver cancer
- intraoperative ablation
- contraindication for liver resection
- preoperative treatment for hepatocellular
- active hepatitis
Show all 10Show fewer
- pregnant
- multi-original tumors
- mixed liver cancer (hepatocellular carcinoma and cholangiocellular carcinoma)
- tumor recurrence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anatomy-based Resection or Margin-based Resection for Hepatocellular Carcinoma: A Randomized Controlled Trial
Anatomical liver resection was widely accepted as first line curative therapy for hepatocellular carcinoma. However, number of retrospective clinical studies showed no priority of anatomical resection for hepatocellular, compared with non-anatomical resection.
Surgical resection margin is a essential factor that may affect tumor prognosis. It is controversial whether adequate liver resection margin is associated with improved survival outcome in patients with hepatocellular.
There was few prospective clinical trial to investigate whether anatomical liver resection is superior to non-anatomical resection or liver resection with adequate margin is superior to that with inadequate margin. This prospective clinical trial aims at fix these issues.
Read the detailed description
In the anatomical liver resection group, liver segmentectomy or lobectomy is performed to insure curative resection (R0 resection). The region of liver resected is based on the anatomy or portal vein and hepatic vein. The liver pedicle of the tumor located lobe is exposed and dissected, which is principle to perform anatomical liver resection.
In the non-anatomical liver resection group, the liver parenchyma transection is around 0-2 cm from the tumor margin, according to tumor size and location.
- Conditions
- Hepatocellular Carcinoma by BCLC Stage
- Being tested
- anatomical liver resection
- Keywords
- hepatocellular carcinoma, anatomical liver 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.
anatomical liver resectionProcedure or surgery
Also called non-anatomical liver resection
Liver resection is performed to achieve R0 resection for patients with appropriate BCLC staging, indocyanine green retention rate, Child-pugh grading and adequate liver remnant.
| Study group | Role | What they receive |
|---|---|---|
| anatomical liver resection | Experimental | resect the tumor located liver segment or lobe Receives: Procedure: anatomical liver resection |
| resection margin based liver resection | Experimental | non-anatomical liver resection, but insure adequate resection margin Receives: Procedure: anatomical liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
prognosis
3 year and 5 year overall survival and disease free survival
Measured: 5 years
Secondary outcomes (2)
postoperative recovery
postoperative complications
Measured: 30 days postoperatively
hospital stay
hospital days after operation
Measured: 60 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start1 Jan 2019 (estimated)
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma by BCLC StageStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoping Chen, Huazhong University of Science and Technology
- Investigators
- Xiaoping Chen, M.D., Principal investigator, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652896
- Sponsor's protocol ID
- AR2018MR
- Status last verified
- Aug 2018
- First submitted
- 20 Aug 2018
- Last updated
- 29 Aug 2018
- 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 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomy-based Resection or Margin-based Resection for Hepatocellular Carcinoma: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03652896
- Acronym / sponsor ID
- AR2018MR
- Conditions
- Hepatocellular Carcinoma by BCLC Stage
- Keywords
- hepatocellular carcinoma, anatomical liver resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 29 Aug 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.
Anatomical liver resection was widely accepted as first line curative therapy for hepatocellular carcinoma. However, number of retrospective clinical studies showed no priority of anatomical resection for hepatocellular, compared with non-anatomical resection.
Surgical resection margin is a essential factor that may affect tumor prognosis. It is controversial whether adequate liver resection margin is associated with improved survival outcome in patients with hepatocellular.
There was few prospective clinical trial to investigate whether anatomical liver resection is superior to non-anatomical resection or liver resection with adequate margin is superior to that with inadequate margin. This prospective clinical trial aims at fix these issues.
Detailed description
In the anatomical liver resection group, liver segmentectomy or lobectomy is performed to insure curative resection (R0 resection). The region of liver resected is based on the anatomy or portal vein and hepatic vein. The liver pedicle of the tumor located lobe is exposed and dissected, which is principle to perform anatomical liver resection.
In the non-anatomical liver resection group, the liver parenchyma transection is around 0-2 cm from the tumor margin, according to tumor size and location.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anatomical liver resection | Experimental | Procedure: anatomical liver resectionresect the tumor located liver segment or lobe |
| resection margin based liver resection | Experimental | Procedure: anatomical liver resectionnon-anatomical liver resection, but insure adequate resection margin |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- patients diagnosed with hepatocellular carcinoma of BCLC stage A
- liver function Child-pugh A
- normal indocyanine green retention rate
- adequate liver remnant
Key exclusion criteria (10 listed)
- age less than 17 y or older than 65 y
- unresectable liver cancer
- intraoperative ablation
- contraindication for liver resection
- preoperative treatment for hepatocellular
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 |
|---|---|---|
| anatomical liver resectionAlso: non-anatomical liver resectionLiver resection is performed to achieve R0 resection for patients with appropriate BCLC staging, indocyanine green retention rate, Child-pugh grading and adequate liver remnant. | Procedure or surgery | anatomical liver resection, resection margin based liver resection |
Primary outcome
prognosis
Time frame: 5 years
3 year and 5 year overall survival and disease free survival
2 secondary outcomes
postoperative recovery
Time frame: 30 days postoperatively
hospital stay
Time frame: 60 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
Related trials for Hepatocellular Carcinoma by BCLC Stage
RecruitingPhase 2
BITS-TO-HCC Study: HAIC+Iparomlimab/Tuvonralimab + Bevacizumab + Surgery/SBRT for BCLC-C HCC With PVTT and/or Oligometastases
Hepatocellular Carcinoma, Portal Vein Tumor Thrombus
RecruitingPhase 2
Photon Radiotherapy Plus Tremelimumab/Durvalumab for BCLC Stage B and C HCC
HCC - Hepatocellular Carcinoma, Tremelimumab
RecruitingPhase 2
Proton Radiotherapy Plus Tremelimumab/Durvalumab for BCLC Stage B and C HCC
HCC - Hepatocellular Carcinoma, Durvalumab
Active, not recruitingPhase 3
Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (HCC)
Advanced Hepatocellular Carcinoma
Recruiting
TITAN-HCC: Neoadjuvant and Adjuvant QL1706 With TACE in Resectable Hepatocellular Carcinoma Beyond Milan Criteria
Hepatocellular Carcinoma (HCC)
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.
Xiaoping Chen, M.D. principal investigator
Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anatomical liver resection in people with Hepatocellular Carcinoma by BCLC Stage, run by Huazhong University of Science and Technology 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 4 inclusion and 10 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 29 Aug 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Binhao Zhang, M.D. (+86 83663400, bhzhang8@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prognosis (time frame: 5 years). 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 29 Aug 2018.