Hepatocellular CarcinomaNCT02525965
The Influence of Resection Margin on the Recurrence of Early-stage Hepatocellular Carcinoma
A study testing Wide resection margin >1cm and Narrow resection margin <1cm in people with Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery Hospital at 1 site in China.
Trial summary
Before the surgery, the investigators predict the risk of microvascular invasion (MVI) presence for the early-stage hepatocellular carcinoma according to the nomogram the investigators have created. 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?
- Wide resection margin >1cm and Narrow resection margin <1cm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to Dec 2017
- 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
- Male or female patients > 18 years and <=70 years of age.
- Diagnosed with HCC according to the criteria of American Association for the Study of Liver Diseases (AASLD).
- Fulfill the Milan criteria.
- High-risk of microvascular invasion (MVI).
- Nomogram score >200.
- Performance status score is 0-1 before the surgery.
- Without or mild liver cirrhosis and the liver function is Child A class.
- Without any other treatments such as TACE、PEI、PRFA before the surgery.
Who cannot join
- Patients with macro tumor thrombus or extrahepatic metastasis.
- Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction.
- Subjects accepting other trial drugs or participating in other clinical trials.
- Patients refuse to join our trial.
- Female with pregnancy or during the lactation period.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality, 200438
Shen Feng, MD, 0086-021-25070805, shenfengdfgd@yahoo.com.cn
Wu Dong, MD, 0086-021-25070765, wuyuz@yahoo.com.cn
About this study
Official title: The Influence of Resection Margin on the Recurrence of Early-stage Hepatocellular Carcinoma After Hepatectomy: a Randomized Controlled Trial
Before the surgery, the investigators predict the risk of microvascular invasion (MVI) presence for the early-stage hepatocellular carcinoma according to the nomogram the investigators have created. Patients with a high risk of microvascular invasion were randomly chose to give the treatment of a wide resection margin, which establish an individualized anti-recurrence program based on the high-grade evidence-based medicine.
Read the detailed description
Although liver resection is still the first line of treatment for hepatocellular carcinoma (HCC) presently, 5-year overall recurrence rates > 70%, the same with early-stage hepatocellular carcinoma, for some studies reported the rates > 40%. Recurrence is also the first cause of death in these patients, so recurrence is the most important factors affecting surgical results of HCC. For the precaution of cancer recurrence, there are no proven techniques for clinical reference at present.
For now, there has been many controversies on the impact about the width of liver resection margin on curative effect. Poon has proven that there is no significant difference in recurrence rate between resection margin > 1cm and resection margin < 1cm. However, Shi et al published a randomized controlled trial: for patients with a solitary tumor, resection margin > 2cm can reduce the recurrence rate after hepatectomy. This is also the only randomized clinical trial study which proves increaseing resection margin will benefit the clinical results at present. A meta analysis consist of 18 studies proves that whether the resection margin has a relationship with a benefit clinical result still needs a further verification.
On the other hand, because microvascular invasion (MVI) is the direct evidence of the micro metastasis in hepatocellular carcinoma, it will decrease recurrence rate for the patients with a high MVI risk, if the investigators increase the resection margin width during the surgery? Shanghai Eastern Hepatobiliary Surgery Hospital which the investigators affiliated with had ever conducted a retrospective analysis on consecutive 3263 patients with HCC hepatectomy, the results indicated that a wide resection margin（≥1cm）can benefit those patients with microvascular invasion , nevertheless, the benefit will not present if patients are without microvascular invasion.
Further and better proofs still needs to approval this consequence, of course. In the past，another study of the ours, published online in the Journal of the American Medical Association Surgery, established a nomogram to predict the presence of microvascular invasion in the early-stage hepatocellular carcinoma, it will efficiently predict the occurrence of microvascular invasion in the hepatocellular carcinoma (HCC) fulfilled the Milan criteria. In consideration of the above basis, the investigators will implement a randomized controlled trial to certificate whether it could really reduce the recurrence rate after liver resection for participants with a high MVI risk during the surgery, if the method participants chose is a wide resection margin.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Wide resection margin >1cm, Narrow resection margin <1cm
- Keywords
- Wide resection margin, Recurrence, Early-stage hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wide resection margin >1cmProcedure or surgery
Surgical removal of lesions choosing the method of wide resection margin >1cm
Narrow resection margin <1cmProcedure or surgery
Surgical removal of lesions choosing the method of wide resection margin <1cm
| Study group | Role | What they receive |
|---|---|---|
| Wide resection margin >1cm | Experimental | Surgical removal of lesions choosing the method of wide resection margin >1cm Receives: Procedure: Wide resection margin >1cm |
| Narrow resection margin <1cm | Active comparator | Surgical removal of lesions choosing the method of narrow resection margin <1cm Receives: Procedure: Narrow resection margin <1cm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rates of each group
Measured: 3 years
Secondary outcomes (1)
Occurrence rate of recurrence of each group
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShenFeng, Eastern Hepatobiliary Surgery Hospital
- Investigators
- Shen Feng, MD, Study chair, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525965
- Sponsor's protocol ID
- EHBHLRM-2015-8-10
- Status last verified
- Mar 2016
- First submitted
- 10 Aug 2015
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Resection Margin on the Recurrence of Early-stage Hepatocellular Carcinoma After Hepatectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02525965
- Acronym / sponsor ID
- EHBHLRM-2015-8-10
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Wide resection margin, Recurrence, Early-stage hepatocellular carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 18 Aug 2015 (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.
Before the surgery, the investigators predict the risk of microvascular invasion (MVI) presence for the early-stage hepatocellular carcinoma according to the nomogram the investigators have created. Patients with a high risk of microvascular invasion were randomly chose to give the treatment of a wide resection margin, which establish an individualized anti-recurrence program based on the high-grade evidence-based medicine.
Detailed description
Although liver resection is still the first line of treatment for hepatocellular carcinoma (HCC) presently, 5-year overall recurrence rates > 70%, the same with early-stage hepatocellular carcinoma, for some studies reported the rates > 40%. Recurrence is also the first cause of death in these patients, so recurrence is the most important factors affecting surgical results of HCC. For the precaution of cancer recurrence, there are no proven techniques for clinical reference at present.
For now, there has been many controversies on the impact about the width of liver resection margin on curative effect. Poon has proven that there is no significant difference in recurrence rate between resection margin > 1cm and resection margin < 1cm. However, Shi et al published a randomized controlled trial: for patients with a solitary tumor, resection margin > 2cm can reduce the recurrence rate after hepatectomy. This is also the only randomized clinical trial study which proves increaseing resection margin will benefit the clinical results at present. A meta analysis consist of 18 studies proves that whether the resection margin has a relationship with a benefit clinical result still needs a further verification.
On the other hand, because microvascular invasion (MVI) is the direct evidence of the micro metastasis in hepatocellular carcinoma, it will decrease recurrence rate for the patients with a high MVI risk, if the investigators increase the resection margin width during the surgery? Shanghai Eastern Hepatobiliary Surgery Hospital which the investigators affiliated with had ever conducted a retrospective analysis on consecutive 3263 patients with HCC hepatectomy, the results indicated that a wide resection margin（≥1cm）can benefit those patients with microvascular invasion , nevertheless, the benefit will not present if patients are without microvascular invasion.
Further and better proofs still needs to approval this consequence, of course. In the past，another study of the ours, published online in the Journal of the American Medical Association Surgery, established a nomogram to predict the presence of microvascular invasion in the early-stage hepatocellular carcinoma, it will efficiently predict the occurrence of microvascular invasion in the hepatocellular carcinoma (HCC) fulfilled the Milan criteria. In consideration of the above basis, the investigators will implement a randomized controlled trial to certificate whether it could really reduce the recurrence rate after liver resection for participants with a high MVI risk during the surgery, if the method participants chose is a wide resection margin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wide resection margin >1cm | Experimental | Procedure: Wide resection margin >1cmSurgical removal of lesions choosing the method of wide resection margin >1cm |
| Narrow resection margin <1cm | Active comparator | Procedure: Narrow resection margin <1cmSurgical removal of lesions choosing the method of narrow resection margin <1cm |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients > 18 years and <=70 years of age.
- Diagnosed with HCC according to the criteria of American Association for the Study of Liver Diseases (AASLD).
- Fulfill the Milan criteria.
- High-risk of microvascular invasion (MVI).
- Nomogram score >200.
Key exclusion criteria (5 listed)
- Patients with macro tumor thrombus or extrahepatic metastasis.
- Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction.
- Subjects accepting other trial drugs or participating in other clinical trials.
- Patients refuse to join our trial.
- Female with pregnancy or during the lactation period.
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 |
|---|---|---|
| Wide resection margin >1cmSurgical removal of lesions choosing the method of wide resection margin >1cm | Procedure or surgery | Wide resection margin >1cm |
| Narrow resection margin <1cmSurgical removal of lesions choosing the method of wide resection margin <1cm | Procedure or surgery | Narrow resection margin <1cm |
Primary outcome
Overall survival rates of each group
Time frame: 3 years
1 secondary outcome
Occurrence rate of recurrence of each group
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
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.
Shen Feng, MD study chair
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wide resection margin >1cm and Narrow resection margin <1cm in people with Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery Hospital 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 8 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: status not confirmed, as of the sponsor's last update on 31 Mar 2016. 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 Shen Feng, MD (0086-021-25070805, shenfengdfgd@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival rates of each group (time frame: 3 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 31 Mar 2016.