Hepatocellular CarcinomaNCT02537158
Sorafenib and TACE as Adjuvant Therapy for MVI in HCC Patients After Radical Resection
A study testing Sorafenib and TACE in people with Hepatocellular Carcinoma, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study is a prospective non-randomized controlled study. The purpose of this study is to evaluate the validity and safety of sorafenib and transcatheter arterial chemoembolization (TACE) for microvascular invasion (MVI) in hepatocellular carcinoma (HCC) patients after radical surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Sorafenib and TACE
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to Jul 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years of age;
- The liver tumor has been radically resected;
- Postoperative pathology proved to be hepatocellular carcinoma with negative margin and microvascular invasion;
- Imaging evaluations(CT/MRI) were performed at 1 month after the resection and no area of enhancement was seen;
- Child-Pugh A;
- Eastern Cooperative Oncology Group(ECOG) body condition score (PS) 0-1;
- Then patients understand and voluntarily signed a written informed consent;
Who cannot join
- Recurrent HCC;
- pathology-proved multifocal HCC or HCC with satellite nodules;
- Tumor thrombus in portal vein or inferior vena cava trunk;
- Patients with extrahepatic metastasis found by radiologic or pathologic examination;
- severe dysfunction of the heart, kidney, or other organs.The patients cannot tolerate TACE or sorafenib after general assessment of the situation;
- Enrolled in other clinical study at the same time;
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- Previously treated with other antitumor treatments except the resection;
- The researchers believe that the patient does not fit this study;
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital and Institute, Chinese Academy of Medical Sciences
Beijing, 100026
Xinyu Bi, Doctor, 86-13911792177, beexy1971@163.com
About this study
Official title: Sorafenib and TACE as Adjuvant Therapy for MVI in HCC Patients After Radical Resection:a Non-randomized Controlled Trial
This study is a prospective non-randomized controlled study. The purpose of this study is to evaluate the validity and safety of sorafenib and transcatheter arterial chemoembolization (TACE) for microvascular invasion (MVI) in hepatocellular carcinoma (HCC) patients after radical surgery.
Read the detailed description
HCC is the sixth most common malignancy worldwide.Selected patients with HCC are candidates for potentially curative therapy, such as hepatic resection and liver transplantation. Nevertheless,tumor recurrence is 70 % at 5 years after resection and 15-30 % after liver transplantation,leading to tumor-related death.MVI is currently one of the most critical factors predictive of HCC recurrence.There are no approved effective interventional measures to improve the outcome of this patients with MVI.The purpose of this study is to explore the validity and safety of sorafenib and TACE for MVI in HCC patients after radical resection.The candidates will be assigned to sorafenib group (about 30 cases),TACE group (about 30 patients) and control group (about 30 cases)，according to the willingness of the subject.All patients will be followed up for 3 years and Recurrence-free survival and overall survival will be recorded.
- Conditions
- Hepatocellular Carcinoma
- Keywords
- sorafenib, transcatheter arterial chemoembolization, hepatocellular carcinoma, microvascular invasion
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
sorafenib group patients will accept sorafenib therapy for one year（400 mg bid,orally).
TACEProcedure or surgery
TACE group patients will accept TACE therapy once at a month after resection.
| Study group | Role | What they receive |
|---|---|---|
| sorafenib group | Experimental | sorafenib group patients will accept sorafenib therapy for one year（400 mg bid,orally). Receives: Drug: Sorafenib |
| TACE group | Experimental | TACE group patients will accept TACE therapy once at a month after resection. Receives: Procedure: TACE |
| control group | No intervention | Control group patients will not accept any intervention,except necessary supportive treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence-free survival
Measured: 36 month
Secondary outcomes (1)
overall survival
Measured: 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinyu Bi, Chinese Academy of Medical Sciences
- Investigators
- Xinyu Bi, Doctor, Study director, Cancer Hospital and Institute, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537158
- Sponsor's protocol ID
- CH-GI-077
- Status last verified
- Mar 2016
- First submitted
- 29 Aug 2015
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rodriguez-Peralvarez M, Luong TV, Andreana L, Meyer T, Dhillon AP, Burroughs AK. A systematic review of microvascular invasion in hepatocellular carcinoma: diagnostic and prognostic variability. Ann Surg Oncol. 2013 Jan;20(1):325-39. doi: 10.1245/s10434-012-2513-1. Epub 2012 Nov 13.
PubMed 23149850Sumie S, Nakashima O, Okuda K, Kuromatsu R, Kawaguchi A, Nakano M, Satani M, Yamada S, Okamura S, Hori M, Kakuma T, Torimura T, Sata M. The significance of classifying microvascular invasion in patients with hepatocellular carcinoma. Ann Surg Oncol. 2014 Mar;21(3):1002-9. doi: 10.1245/s10434-013-3376-9. Epub 2013 Nov 20.
PubMed 24254204Roayaie S, Blume IN, Thung SN, Guido M, Fiel MI, Hiotis S, Labow DM, Llovet JM, Schwartz ME. A system of classifying microvascular invasion to predict outcome after resection in patients with hepatocellular carcinoma. Gastroenterology. 2009 Sep;137(3):850-5. doi: 10.1053/j.gastro.2009.06.003. Epub 2009 Jun 12.
PubMed 19524573Zhu YB, Xu X, Zheng SS. [Association of microvascular invasion with recurrence and prognosis of patients with small hepatocellular carcinoma undergoing liver transplantation]. Zhejiang Da Xue Xue Bao Yi Xue Ban. 2014 Nov;43(6):658-63. doi: 10.3785/j.issn.1008-9292.2014.11.004. Chinese.
PubMed 25644564Shirabe K, Toshima T, Kimura K, Yamashita Y, Ikeda T, Ikegami T, Yoshizumi T, Abe K, Aishima S, Maehara Y. New scoring system for prediction of microvascular invasion in patients with hepatocellular carcinoma. Liver Int. 2014 Jul;34(6):937-41. doi: 10.1111/liv.12459. Epub 2014 Jan 24.
PubMed 24393295Meniconi RL, Komatsu S, Perdigao F, Boelle PY, Soubrane O, Scatton O. Recurrent hepatocellular carcinoma: a Western strategy that emphasizes the impact of pathologic profile of the first resection. Surgery. 2015 Mar;157(3):454-62. doi: 10.1016/j.surg.2014.10.011. Epub 2014 Nov 6.
PubMed 25633732
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sorafenib and TACE as Adjuvant Therapy for MVI in HCC Patients After Radical Resection:a Non-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02537158
- Acronym / sponsor ID
- CH-GI-077
- Conditions
- Hepatocellular Carcinoma
- Keywords
- sorafenib, transcatheter arterial chemoembolization, hepatocellular carcinoma, microvascular invasion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 1 Sep 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.
This study is a prospective non-randomized controlled study. The purpose of this study is to evaluate the validity and safety of sorafenib and transcatheter arterial chemoembolization (TACE) for microvascular invasion (MVI) in hepatocellular carcinoma (HCC) patients after radical surgery.
Detailed description
HCC is the sixth most common malignancy worldwide.Selected patients with HCC are candidates for potentially curative therapy, such as hepatic resection and liver transplantation. Nevertheless,tumor recurrence is 70 % at 5 years after resection and 15-30 % after liver transplantation,leading to tumor-related death.MVI is currently one of the most critical factors predictive of HCC recurrence.There are no approved effective interventional measures to improve the outcome of this patients with MVI.The purpose of this study is to explore the validity and safety of sorafenib and TACE for MVI in HCC patients after radical resection.The candidates will be assigned to sorafenib group (about 30 cases),TACE group (about 30 patients) and control group (about 30 cases)，according to the willingness of the subject.All patients will be followed up for 3 years and Recurrence-free survival and overall survival will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sorafenib group | Experimental | Drug: Sorafenibsorafenib group patients will accept sorafenib therapy for one year（400 mg bid,orally). |
| TACE group | Experimental | Procedure: TACETACE group patients will accept TACE therapy once at a month after resection. |
| control group | No intervention | –Control group patients will not accept any intervention,except necessary supportive treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-75 years of age;
- The liver tumor has been radically resected;
- Postoperative pathology proved to be hepatocellular carcinoma with negative margin and microvascular invasion;
- Imaging evaluations(CT/MRI) were performed at 1 month after the resection and no area of enhancement was seen;
- Child-Pugh A;
Key exclusion criteria (9 listed)
- Recurrent HCC;
- pathology-proved multifocal HCC or HCC with satellite nodules;
- Tumor thrombus in portal vein or inferior vena cava trunk;
- Patients with extrahepatic metastasis found by radiologic or pathologic examination;
- severe dysfunction of the heart, kidney, or other organs.The patients cannot tolerate TACE or sorafenib after general assessment of the situation;
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 |
|---|---|---|
| Sorafenibsorafenib group patients will accept sorafenib therapy for one year（400 mg bid,orally). | Drug | sorafenib group |
| TACETACE group patients will accept TACE therapy once at a month after resection. | Procedure or surgery | TACE group |
Primary outcome
recurrence-free survival
Time frame: 36 month
1 secondary outcome
overall survival
Time frame: 36 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
- Background: PubMed 23149850Rodriguez-Peralvarez M, Luong TV, Andreana L, Meyer T, Dhillon AP, Burroughs AK. A systematic review of microvascular invasion in hepatocellular carcinoma: diagnostic and prognostic variability. Ann Surg Oncol. 2013 Jan;20(1):325-39. doi: 10.1245/s10434-012-2513-1. Epub 2012 Nov 13.
- Background: PubMed 24254204Sumie S, Nakashima O, Okuda K, Kuromatsu R, Kawaguchi A, Nakano M, Satani M, Yamada S, Okamura S, Hori M, Kakuma T, Torimura T, Sata M. The significance of classifying microvascular invasion in patients with hepatocellular carcinoma. Ann Surg Oncol. 2014 Mar;21(3):1002-9. doi: 10.1245/s10434-013-3376-9. Epub 2013 Nov 20.
- Background: PubMed 19524573Roayaie S, Blume IN, Thung SN, Guido M, Fiel MI, Hiotis S, Labow DM, Llovet JM, Schwartz ME. A system of classifying microvascular invasion to predict outcome after resection in patients with hepatocellular carcinoma. Gastroenterology. 2009 Sep;137(3):850-5. doi: 10.1053/j.gastro.2009.06.003. Epub 2009 Jun 12.
- Background: PubMed 25644564Zhu YB, Xu X, Zheng SS. [Association of microvascular invasion with recurrence and prognosis of patients with small hepatocellular carcinoma undergoing liver transplantation]. Zhejiang Da Xue Xue Bao Yi Xue Ban. 2014 Nov;43(6):658-63. doi: 10.3785/j.issn.1008-9292.2014.11.004. Chinese.
- Background: PubMed 24393295Shirabe K, Toshima T, Kimura K, Yamashita Y, Ikeda T, Ikegami T, Yoshizumi T, Abe K, Aishima S, Maehara Y. New scoring system for prediction of microvascular invasion in patients with hepatocellular carcinoma. Liver Int. 2014 Jul;34(6):937-41. doi: 10.1111/liv.12459. Epub 2014 Jan 24.
- Background: PubMed 25633732Meniconi RL, Komatsu S, Perdigao F, Boelle PY, Soubrane O, Scatton O. Recurrent hepatocellular carcinoma: a Western strategy that emphasizes the impact of pathologic profile of the first resection. Surgery. 2015 Mar;157(3):454-62. doi: 10.1016/j.surg.2014.10.011. Epub 2014 Nov 6.
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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.
Xinyu Bi, Doctor study director
Cancer Hospital and Institute, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sorafenib and TACE in people with Hepatocellular Carcinoma, run by Chinese Academy of Medical Sciences 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 7 inclusion and 9 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 15 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 Xinyu Bi, Doctor (86-13911792177, beexy1971@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence-free survival (time frame: 36 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02537158, which also lists 6 linked publications.
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 15 Mar 2016.