Hepatocellular CarcinomaNCT02525952
Treatment for Patients With Multiple Hepatocellular Carcinomas Based on the NDR Scoring System
A study testing Hepatectomy and TACE in people with Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery Hospital at 2 sites in China.
Trial summary
The aim of this study is to establish a selection criteria of hepatectomy for patients with multiple hepatocellular carcinomas based on the NDR Scoring System 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?
- Hepatectomy and TACE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 2 sitesChina
- Study dates
- Oct 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
- Patients preoperatively diagnosed of hepatocellular carcinoma according to the criteria of American Association for the Study of Liver Diseases(AASLD).
- Preoperative ECOG criteria score of 0-1
- Child-Pugh class A liver function
- Multiple hepatocellular carcinomas with tumor number <=5 and total tumor diameter <=15 cm
Who cannot join
- Major portal/hepatic vein invasion
- Extrahepatic metastasis
- Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer
- Anticancer treatment before surgery
- Lost to follow-up
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Eastern hepatobilliary surgery hospital
Shanghai, Shanghai Municipality, 200438
Yong Xia, Doctor, 86-021-81875495
- 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: A Randomized Controlled Trial to Compare the Outcomes Between Hepatectomy and Transarterial Chemoembolization for Patients With Multiple Hepatocellular Carcinomas Based on the NDR Scoring System
The aim of this study is to establish a selection criteria of hepatectomy for patients with multiple hepatocellular carcinomas based on the NDR Scoring System
Read the detailed description
Multiple hepatocellular carcinomas (HCCs) accounts for 60% to 70% of patients with hepatocellular carcinoma.However,the selection criteria of hepatectomy for patients with multiple HCCs remains controversial.Researches have suggested that part of the patients with multiple HCCs can also benefit from hepatectomy.But,expanding the selection criteria for hepatectomy will increase tumor recurrence rates and reduce the therapeutic effect, more stringent selection criteria will also make part of the patients who should take hepatectomy lose the operation chance. This is a difficult problem in the research of this field.The Barcelona Clinic Liver Cancer (BCLC) system recommends that stage A (number ≤ 3, largest diameter ≤ 3 cm) were suitable for liver resection.However, increasing reports on good outcome after hepatectomy for patients with multiple HCCs have been published.Studies on clonal origin suggest that hepatectomy is a better treatment for multiple HCCs from multicentric origin (MO) than that from intrahepatic metastasis (IM) and the 5-year overall survival rates is 24% to 58%.The investigators established a scoring system(NDR score; N, tumor number; D, total tumor diameter; R, ratio of largest/smallest diameter) based on preoperative data which can accurately predict postoperative long-term survival of patients with multiple HCCs.The formula is as follows: 1×N（N: >3=1; ≤3= 0）+ 2×D（D: >8cm = 1; ≤8cm= 0）+ 1×R（R: >6 = 1; ≤6= 0）.The investigators first propose a selection criteria of hepatectomy for patients with multiple HCCs based on this scoring system. Patients with a NDR score 0-2 are recommended for hepatectomy and can benefit from the surgery,and because of the unsatisfied outcome,patients with a NDR score more than 2 are not recommended for hepatectomy.The stringent selection criteria should be expanded so that more patients can benefit from hepatectomy,and the less stringent criteria should be limited to ensure curative effect.So,the investigators' NDR scoring system was more accurate in selecting patients with multiple HCCs for hepatectomy and this article was published on Ann Surg Oncol（2015，22:826）.In order to further confirm the rationality of this selection criteria,the investigators would like to propose a prospective randomized controlled study.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Hepatectomy, TACE
- Keywords
- Carcinoma, Hepatocellular, Hepatectomy, Transarterial Chemoembolization, Scoring System
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepatectomyProcedure or surgery
Surgical removal of all lesions
TACEProcedure or surgery
Transarterial chemoembolization with lipiodol and pirarubicin
| Study group | Role | What they receive |
|---|---|---|
| Hepatectomy with NDR 0-2 | Experimental | Surgical removal of all lesions for patients with a NDR score 0-2 according to the NDR scoring system Receives: Procedure: Hepatectomy |
| TACE with NDR 0-2 | Active comparator | Transarterial chemoembolization for patients with a NDR score 0-2 according to the NDR scoring system Receives: Procedure: TACE |
| Hepatectomy with NDR >2 | Experimental | Surgical removal of all lesions for patients with a NDR score more than 2 according to the NDR scoring system Receives: Procedure: Hepatectomy |
| TACE with NDR >2 | Active comparator | Transarterial chemoembolization for patients with a NDR score more than 2 according to the NDR scoring system Receives: Procedure: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 5 years
Secondary outcomes (1)
Time to recurrence
Measured: 5 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 startOct 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
- 320 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
- NCT02525952
- Sponsor's protocol ID
- EHBHKY2015-01-012
- 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
- A Randomized Controlled Trial to Compare the Outcomes Between Hepatectomy and Transarterial Chemoembolization for Patients With Multiple Hepatocellular Carcinomas Based on the NDR Scoring System
- ClinicalTrials.gov ID
- NCT02525952
- Acronym / sponsor ID
- EHBHKY2015-01-012
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Carcinoma, Hepatocellular, Hepatectomy, Transarterial Chemoembolization, Scoring System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- Oct 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.
The aim of this study is to establish a selection criteria of hepatectomy for patients with multiple hepatocellular carcinomas based on the NDR Scoring System
Detailed description
Multiple hepatocellular carcinomas (HCCs) accounts for 60% to 70% of patients with hepatocellular carcinoma.However,the selection criteria of hepatectomy for patients with multiple HCCs remains controversial.Researches have suggested that part of the patients with multiple HCCs can also benefit from hepatectomy.But,expanding the selection criteria for hepatectomy will increase tumor recurrence rates and reduce the therapeutic effect, more stringent selection criteria will also make part of the patients who should take hepatectomy lose the operation chance. This is a difficult problem in the research of this field.The Barcelona Clinic Liver Cancer (BCLC) system recommends that stage A (number ≤ 3, largest diameter ≤ 3 cm) were suitable for liver resection.However, increasing reports on good outcome after hepatectomy for patients with multiple HCCs have been published.Studies on clonal origin suggest that hepatectomy is a better treatment for multiple HCCs from multicentric origin (MO) than that from intrahepatic metastasis (IM) and the 5-year overall survival rates is 24% to 58%.The investigators established a scoring system(NDR score; N, tumor number; D, total tumor diameter; R, ratio of largest/smallest diameter) based on preoperative data which can accurately predict postoperative long-term survival of patients with multiple HCCs.The formula is as follows: 1×N（N: >3=1; ≤3= 0）+ 2×D（D: >8cm = 1; ≤8cm= 0）+ 1×R（R: >6 = 1; ≤6= 0）.The investigators first propose a selection criteria of hepatectomy for patients with multiple HCCs based on this scoring system. Patients with a NDR score 0-2 are recommended for hepatectomy and can benefit from the surgery,and because of the unsatisfied outcome,patients with a NDR score more than 2 are not recommended for hepatectomy.The stringent selection criteria should be expanded so that more patients can benefit from hepatectomy,and the less stringent criteria should be limited to ensure curative effect.So,the investigators' NDR scoring system was more accurate in selecting patients with multiple HCCs for hepatectomy and this article was published on Ann Surg Oncol（2015，22:826）.In order to further confirm the rationality of this selection criteria,the investigators would like to propose a prospective randomized controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hepatectomy with NDR 0-2 | Experimental | Procedure: HepatectomySurgical removal of all lesions for patients with a NDR score 0-2 according to the NDR scoring system |
| TACE with NDR 0-2 | Active comparator | Procedure: TACETransarterial chemoembolization for patients with a NDR score 0-2 according to the NDR scoring system |
| Hepatectomy with NDR >2 | Experimental | Procedure: HepatectomySurgical removal of all lesions for patients with a NDR score more than 2 according to the NDR scoring system |
| TACE with NDR >2 | Active comparator | Procedure: TACETransarterial chemoembolization for patients with a NDR score more than 2 according to the NDR scoring system |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients > 18 years and <=70 years of age
- Patients preoperatively diagnosed of hepatocellular carcinoma according to the criteria of American Association for the Study of Liver Diseases(AASLD).
- Preoperative ECOG criteria score of 0-1
- Child-Pugh class A liver function
- Multiple hepatocellular carcinomas with tumor number <=5 and total tumor diameter <=15 cm
Key exclusion criteria (5 listed)
- Major portal/hepatic vein invasion
- Extrahepatic metastasis
- Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer
- Anticancer treatment before surgery
- Lost to follow-up
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 |
|---|---|---|
| HepatectomySurgical removal of all lesions | Procedure or surgery | Hepatectomy with NDR 0-2, Hepatectomy with NDR >2 |
| TACETransarterial chemoembolization with lipiodol and pirarubicin | Procedure or surgery | TACE with NDR 0-2, TACE with NDR >2 |
Primary outcome
overall survival
Time frame: 5 years
1 secondary outcome
Time to recurrence
Time frame: 5 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.
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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.
Shen Feng, MD study chair
Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hepatectomy and TACE in people with Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery Hospital at 2 sites 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 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 2 sites 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 (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 31 Mar 2016.