Hepatocellular CarcinomaPhase 2COTSOMNCT02311205
Efficacy and Safety of Concurrent TACE and Sorafenib in Patients With HCC and Extrahepatic Metastasis (COTSOM Study)
A Phase 2 study testing Conventional Transarterial Chemoembolization (TACE) and sorafenib in people with Hepatocellular Carcinoma and Metastasis, run by Asan Medical Center at 1 site in South Korea.
Trial summary
This study is a phase II, prospective, open-label, single arm, single center study of the efficacy and safety of concurrent conventional transarterial chemoembolization (TACE) and sorafenib in patients with hepatocellular carcinoma and extrahepatic metastasis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Metastasis
- What is being tested?
- Conventional Transarterial Chemoembolization (TACE) and sorafenib
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2014to Jun 2018
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with HCC and newly diagnosed extrahepatic metastasis meeting of following criteria
- Clinical or histological diagnosis of HCC based on the guidelines: Early enhancement followed by late wash-out on dynamic liver imaging (CT or MRI) Or Pathological examination of liver biopsy
- Evidence of extrahepatic metastasis with any of following methods; CT, MRI, bone scan, positron emission tomography with FDG-PET, biopsy of metastatic lesion
- Preserved liver function classified as Child-Pugh A
- ECOG PS of 0-1
- Age of at least 20 years
Show all 10Show fewer
- Patients is able to comply with scheduled visits, evaluation plan, and other study procedures
- Patient is willing to provide written informed consent
- There is no limitation of prior TACE session number in case that further TACE is still considered to be beneficial
- Women of childbearing potential must have a negative pregnancy test performed within 14 days of the start of treatment. All patients of child-bearing potential must use adequate birth control measures during the course of the trial (barrier method of birth control) and up to at least 30 days of last dose.
Who cannot join
- Presence of any of following criteria
- Patients who are diagnosed as not eligible for further TACE before screening
- Patients with advanced liver disease as defined below:
- Child Pugh B and C
- Encephalopathy
- Ascites
Show all 35Show fewer
- Complete occlusion of main portal vein (PV) by HCC
- Patients with brain metastasis
- Inadequate liver function that could not perform TACE:
- AST > 5 X ULN(upper limit normal) or ALT > 5 X ULN
- Total bilirubin > 2.0 mg/dL
- Prothrombin time INR > 1.7
- Inadequate bone marrow function (absolute neutrophil count < 1,500/μL, Hemoglobin (Hgb) < 8 g/dL, platelet count < 50,000/μL)
- Inadequate renal function (creatinine > 1.5 x ULN)
- Treatment with previous local therapy such as resection of HCC, radiofrequency ablation (RFA), percutaneous ethanol injection (PEI) < 4 weeks prior to the screening
- Prior sorafenib use
- Investigational drugs or other molecular target drugs ongoing or completed < 4 weeks prior to the screening
- Clinically significant gastrointestinal bleeding within 4 weeks prior to start of study drug
- Uncontrolled bleeding varices.
- History of cardiac disease:
- Congestive heart failure >NYHA class 2
- Active coronary artery disease (CAD) (myocardial infarction more than 6 months prior to study entry is allowed)
- Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before screening
- Cardiac arrhythmias which are poorly controlled with anti-arrhythmic therapy or requiring pace maker
- Uncontrolled hypertension
- Active clinically serious infections except for HBV and HCV infection
- Patients with HIV
- Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) within 6 months before screening
- Recently treated or concurrent cancer that has a primary site or histology distinct from HCC except any cancer curatively treated more than 3 years prior to screening
- Pregnant or breast-feeding subjects
- Major surgery, open biopsy, or significant traumatic injury 4 weeks before screening
- Presence of a non-healing wound, non-healing ulcer, or bone fracture
- Subjects who have used strong CYP3A4 inducers within 4 weeks before screening
- Known or suspected allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of this trial
- Any other condition which, in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with the completing the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Prospective, Open-label, Single Arm Study of the Efficacy and Safety of Concurrent Conventional TACE and Sorafenib in Patients With Hepatocellular Carcinoma and Extrahepatic Metastasis (COTSOM Study)
This study is a phase II, prospective, open-label, single arm, single center study of the efficacy and safety of concurrent conventional transarterial chemoembolization (TACE) and sorafenib in patients with hepatocellular carcinoma and extrahepatic metastasis. All of the 55 patients with hepatocellular carcinoma and newly diagnosed extrahepatic (lung, bone, lymph node, adrenal gland) metastasis will be included.
On demand conventional TACE will be performed in all the patients after enrollment and can be continued until intrahepatic CR, TACE failure or consent withdrawal. Sorafenib will be started 3-7 days after the first and each subsequent TACE and stopped one day before next TACE and will be continued until sorafenib failure, consent withdrawal or condition worsening by clinical decision. Repeated on-demand TACE and sorafenib should continue until the criteria for treatment discontinuation are met. After initiation of sorafenib combination treatment, patients will be seen and will perform routine examination at week 4 and, after then routine examination will be followed every 6 ± 2 weeks.
Read the detailed description
This is a single center, single arm, prospective, phase II study in patients with metastatic HCC. A total of 55 patients with HCC and newly diagnosed extrahepatic (lung, bone, lymph node, adrenal gland) metastasis will be enrolled.
On demand conventional TACE will be performed in all the patients after enrollment and can be continued until intrahepatic CR, TACE failure or consent withdrawal. Safety will be evaluated every 6 ± 2 weeks after initial TACE and closed monitoring at unscheduled visit will be done as well. The efficacy of TACE will be evaluated every 6 ± 2 weeks after each session of TACE using dynamic CT or MRI. Performance of repeated TACE will be decided based on the findings of follow-up CT, patients' liver function and performance status, within 6 ± 2 weeks of the previous TACE. Patients with no residual viable tumors after previous TACE who are not indicated for further TACE are evaluated with routine examination and imaging studies every 6 ± 2 weeks. Safety should be evaluated on an ongoing basis and within 3 days of next TACE. All eligible patients will be given sorafenib (initially 400mg po bid) on day 3-7 after the first or every session of TACE, and sorafenib will be stopped one day before each TACE. Sorafenib will be continued until sorafenib failure, consent withdrawal or condition worsening by clinical decision. Treatment failure will be judged by the evaluation of intra- or extrahepatic lesion separately. TACE failure is defined as when TACE/transarterial chemo-lipiodolization (TACL) has no more benefit by clinical assessment which is judged clinically by one investigator and/or the patient is not more eligible because of worsening of ECOG PS or liver function. Detailed criteria for stopping TACE will be clarified in below. Sorafenib failure will be evaluated by modified RECIST applied to the extrahepatic lesion, and sorafenib will be stopped when progressive disease (PD) by mRECIST for extrahepatic lesion is indicated and clinical benefit of TACE is not expected for intrahepatic lesion. As long as TACE is evaluated to be beneficial and planned to be performed by investigator, sorafenib could be continued if side effect is tolerable.
When any of the treatment discontinuation criteria is met, test treatment will be stopped. Survival and post-treatment information will be collected at 1-3 months intervals after the last study visit until the endpoint of death, or until the subject has become lost to follow-up or until study termination by Principal Investigator. Additional palliative anti-cancer therapies such as cytotoxic chemotherapy and TACL without gelfoam embolization and palliative radiation therapy will be allowed and recorded.
- Conditions
- Hepatocellular Carcinoma, Metastasis
- Being tested
- Conventional Transarterial Chemoembolization (TACE), sorafenib
- Keywords
- Transarterial Chemoembolization (TACE), Hepatocellular carcinoma (HCC), Metastasis, Sorafenib
- Medical subject headings
- Carcinoma, Hepatocellular, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Transarterial Chemoembolization (TACE)Procedure or surgery
On demand conventional TACE will be performed in all the patients after enrollment and can be continued until intrahepatic CR, TACE failure or consent withdrawal. Sorafenib will be started 3-7 days after the first and each subsequent TACE and stopped one day before next TACE and will be continued until sorafenib failure, consent withdrawal or condition worsening by clinical decision.
sorafenibDrug
Also called nexavar
Sorafenib will be started 3-7 days after the first and each subsequent TACE and stopped one day before next TACE and will be continued until sorafenib failure, consent withdrawal or condition worsening by clinical decision.
| Study group | Role | What they receive |
|---|---|---|
| TACE+sorafenib | Experimental | Concurrent Conventional Transarterial Chemoembolization (TACE) and Sorafenib Receives: Procedure: Conventional Transarterial Chemoembolization (TACE); Drug: sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Overall survival (OS) from the start of first TACE as a part of combination treatment
Measured: Up to 1 year from the start of first TACE as a part of combination treatment
Secondary outcomes (7)
Safety (adverse events and laboratory values)
adverse events and laboratory values
Measured: Up to 1 year from the start of first TACE as a part of combination treatment
Liver dysfunction (laboratory values related to liver)
Liver dysfunction (laboratory values related to liver)
Measured: Up to 1 year from the start of first TACE as a part of combination treatment
Time to progression (TTP)
Measured: Up to 1 year from the start of first TACE as a part of combination treatment
Time to TACE failure (TTTF)
Measured: Up to 1 year from the start of first TACE as a part of combination treatment
Time to sorafenib failure (TTSF)
Measured: Up to 1 year from the start of first TACE as a part of combination treatment
Tumor response rate (TRR)
defined as the sum of complete response and partial response, overall, intrahepatic or extrahepatic response respectively
Measured: Up to 1 year from the start of first TACE as a part of combination treatment
Disease control rate (DCR)
defined as the sum of complete response, partial response and stable disease, overall, intrahepatic or extrahepatic response respectively. SD will be decided when it last at least more than 4 weeks.
Measured: Up to 1 year from the start of first TACE as a part of combination treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Kang Mo Kim, Asan Medical Center
- Investigators
- Kang Mo Kim, MD, PhD, Principal investigator, Asan Medical Center, University of Ulsan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311205
- Sponsor's protocol ID
- 2014-0902
- Acronym
- COTSOM
- Status last verified
- Dec 2017
- First submitted
- 3 Dec 2014
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bruix J, Sherman M; Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005 Nov;42(5):1208-36. doi: 10.1002/hep.20933. No abstract available.
PubMed 16250051Pang RW, Poon RT. From molecular biology to targeted therapies for hepatocellular carcinoma: the future is now. Oncology. 2007;72 Suppl 1:30-44. doi: 10.1159/000111705. Epub 2007 Dec 13.
PubMed 18087180Kim KM, Kim JH, Park IS, Ko GY, Yoon HK, Sung KB, Lim YS, Lee HC, Chung YH, Lee YS, Suh DJ. Reappraisal of repeated transarterial chemoembolization in the treatment of hepatocellular carcinoma with portal vein invasion. J Gastroenterol Hepatol. 2009 May;24(5):806-14. doi: 10.1111/j.1440-1746.2008.05728.x. Epub 2009 Jan 13.
PubMed 19207681Kudo M, Izumi N, Kokudo N, Matsui O, Sakamoto M, Nakashima O, Kojiro M, Makuuchi M; HCC Expert Panel of Japan Society of Hepatology. Management of hepatocellular carcinoma in Japan: Consensus-Based Clinical Practice Guidelines proposed by the Japan Society of Hepatology (JSH) 2010 updated version. Dig Dis. 2011;29(3):339-64. doi: 10.1159/000327577. Epub 2011 Aug 9.
PubMed 21829027Yoo DJ, Kim KM, Jin YJ, Shim JH, Ko GY, Yoon HK, Sung KB, Lee JL, Kang YK, Lim YS, Lee HC, Chung YH, Lee YS, Suh DJ. Clinical outcome of 251 patients with extrahepatic metastasis at initial diagnosis of hepatocellular carcinoma: does transarterial chemoembolization improve survival in these patients? J Gastroenterol Hepatol. 2011 Jan;26(1):145-54. doi: 10.1111/j.1440-1746.2010.06341.x.
PubMed 21175808Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.
PubMed 18650514Lencioni R, Llovet JM. Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin Liver Dis. 2010 Feb;30(1):52-60. doi: 10.1055/s-0030-1247132. Epub 2010 Feb 19.
PubMed 20175033
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Prospective, Open-label, Single Arm Study of the Efficacy and Safety of Concurrent Conventional TACE and Sorafenib in Patients With Hepatocellular Carcinoma and Extrahepatic Metastasis (COTSOM Study)
- ClinicalTrials.gov ID
- NCT02311205
- Acronym / sponsor ID
- COTSOM / 2014-0902
- Conditions
- Hepatocellular Carcinoma, Metastasis
- Keywords
- Transarterial Chemoembolization (TACE), Hepatocellular carcinoma (HCC), Metastasis, Sorafenib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Dec 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 8 Dec 2014 (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 phase II, prospective, open-label, single arm, single center study of the efficacy and safety of concurrent conventional transarterial chemoembolization (TACE) and sorafenib in patients with hepatocellular carcinoma and extrahepatic metastasis. All of the 55 patients with hepatocellular carcinoma and newly diagnosed extrahepatic (lung, bone, lymph node, adrenal gland) metastasis will be included.
On demand conventional TACE will be performed in all the patients after enrollment and can be continued until intrahepatic CR, TACE failure or consent withdrawal. Sorafenib will be started 3-7 days after the first and each subsequent TACE and stopped one day before next TACE and will be continued until sorafenib failure, consent withdrawal or condition worsening by clinical decision. Repeated on-demand TACE and sorafenib should continue until the criteria for treatment discontinuation are met. After initiation of sorafenib combination treatment, patients will be seen and will perform routine examination at week 4 and, after then routine examination will be followed every 6 ± 2 weeks.
Detailed description
This is a single center, single arm, prospective, phase II study in patients with metastatic HCC. A total of 55 patients with HCC and newly diagnosed extrahepatic (lung, bone, lymph node, adrenal gland) metastasis will be enrolled.
On demand conventional TACE will be performed in all the patients after enrollment and can be continued until intrahepatic CR, TACE failure or consent withdrawal. Safety will be evaluated every 6 ± 2 weeks after initial TACE and closed monitoring at unscheduled visit will be done as well. The efficacy of TACE will be evaluated every 6 ± 2 weeks after each session of TACE using dynamic CT or MRI. Performance of repeated TACE will be decided based on the findings of follow-up CT, patients' liver function and performance status, within 6 ± 2 weeks of the previous TACE. Patients with no residual viable tumors after previous TACE who are not indicated for further TACE are evaluated with routine examination and imaging studies every 6 ± 2 weeks. Safety should be evaluated on an ongoing basis and within 3 days of next TACE. All eligible patients will be given sorafenib (initially 400mg po bid) on day 3-7 after the first or every session of TACE, and sorafenib will be stopped one day before each TACE. Sorafenib will be continued until sorafenib failure, consent withdrawal or condition worsening by clinical decision. Treatment failure will be judged by the evaluation of intra- or extrahepatic lesion separately. TACE failure is defined as when TACE/transarterial chemo-lipiodolization (TACL) has no more benefit by clinical assessment which is judged clinically by one investigator and/or the patient is not more eligible because of worsening of ECOG PS or liver function. Detailed criteria for stopping TACE will be clarified in below. Sorafenib failure will be evaluated by modified RECIST applied to the extrahepatic lesion, and sorafenib will be stopped when progressive disease (PD) by mRECIST for extrahepatic lesion is indicated and clinical benefit of TACE is not expected for intrahepatic lesion. As long as TACE is evaluated to be beneficial and planned to be performed by investigator, sorafenib could be continued if side effect is tolerable.
When any of the treatment discontinuation criteria is met, test treatment will be stopped. Survival and post-treatment information will be collected at 1-3 months intervals after the last study visit until the endpoint of death, or until the subject has become lost to follow-up or until study termination by Principal Investigator. Additional palliative anti-cancer therapies such as cytotoxic chemotherapy and TACL without gelfoam embolization and palliative radiation therapy will be allowed and recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TACE+sorafenib | Experimental | Procedure: Conventional Transarterial Chemoembolization (TACE), Drug: sorafenibConcurrent Conventional Transarterial Chemoembolization (TACE) and Sorafenib |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with HCC and newly diagnosed extrahepatic metastasis meeting of following criteria
Key exclusion criteria (35 listed)
- Presence of any of following criteria
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 |
|---|---|---|
| Conventional Transarterial Chemoembolization (TACE)On demand conventional TACE will be performed in all the patients after enrollment and can be continued until intrahepatic CR, TACE failure or consent withdrawal. Sorafenib will be started 3-7 days after the first and each subsequent TACE and stopped one day before next TACE and will be continued until sorafenib failure, consent withdrawal or condition worsening by clinical decision. | Procedure or surgery | TACE+sorafenib |
| sorafenibAlso: nexavarSorafenib will be started 3-7 days after the first and each subsequent TACE and stopped one day before next TACE and will be continued until sorafenib failure, consent withdrawal or condition worsening by clinical decision. | Drug | TACE+sorafenib |
Primary outcome
Overall survival (OS)
Time frame: Up to 1 year from the start of first TACE as a part of combination treatment
Overall survival (OS) from the start of first TACE as a part of combination treatment
7 secondary outcomes
Safety (adverse events and laboratory values)
Time frame: Up to 1 year from the start of first TACE as a part of combination treatment
Liver dysfunction (laboratory values related to liver)
Time frame: Up to 1 year from the start of first TACE as a part of combination treatment
Time to progression (TTP)
Time frame: Up to 1 year from the start of first TACE as a part of combination treatment
Time to TACE failure (TTTF)
Time frame: Up to 1 year from the start of first TACE as a part of combination treatment
Time to sorafenib failure (TTSF)
Time frame: Up to 1 year from the start of first TACE as a part of combination treatment
Tumor response rate (TRR)
Time frame: Up to 1 year from the start of first TACE as a part of combination treatment
Disease control rate (DCR)
Time frame: Up to 1 year from the start of first TACE as a part of combination treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Background: PubMed 16250051Bruix J, Sherman M; Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005 Nov;42(5):1208-36. doi: 10.1002/hep.20933. No abstract available.
- Background: PubMed 18087180Pang RW, Poon RT. From molecular biology to targeted therapies for hepatocellular carcinoma: the future is now. Oncology. 2007;72 Suppl 1:30-44. doi: 10.1159/000111705. Epub 2007 Dec 13.
- Background: PubMed 19207681Kim KM, Kim JH, Park IS, Ko GY, Yoon HK, Sung KB, Lim YS, Lee HC, Chung YH, Lee YS, Suh DJ. Reappraisal of repeated transarterial chemoembolization in the treatment of hepatocellular carcinoma with portal vein invasion. J Gastroenterol Hepatol. 2009 May;24(5):806-14. doi: 10.1111/j.1440-1746.2008.05728.x. Epub 2009 Jan 13.
- Background: PubMed 21829027Kudo M, Izumi N, Kokudo N, Matsui O, Sakamoto M, Nakashima O, Kojiro M, Makuuchi M; HCC Expert Panel of Japan Society of Hepatology. Management of hepatocellular carcinoma in Japan: Consensus-Based Clinical Practice Guidelines proposed by the Japan Society of Hepatology (JSH) 2010 updated version. Dig Dis. 2011;29(3):339-64. doi: 10.1159/000327577. Epub 2011 Aug 9.
- Background: PubMed 21175808Yoo DJ, Kim KM, Jin YJ, Shim JH, Ko GY, Yoon HK, Sung KB, Lee JL, Kang YK, Lim YS, Lee HC, Chung YH, Lee YS, Suh DJ. Clinical outcome of 251 patients with extrahepatic metastasis at initial diagnosis of hepatocellular carcinoma: does transarterial chemoembolization improve survival in these patients? J Gastroenterol Hepatol. 2011 Jan;26(1):145-54. doi: 10.1111/j.1440-1746.2010.06341.x.
- Background: PubMed 18650514Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.
- Background: PubMed 20175033Lencioni R, Llovet JM. Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin Liver Dis. 2010 Feb;30(1):52-60. doi: 10.1055/s-0030-1247132. Epub 2010 Feb 19.
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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.
Kang Mo Kim, MD, PhD principal investigator
Asan Medical Center, University of Ulsan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Conventional Transarterial Chemoembolization (TACE) and sorafenib in people with Hepatocellular Carcinoma and Metastasis, run by Asan Medical Center at 1 site in South Korea.
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 10 inclusion and 35 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 18 Dec 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 South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Overall survival (OS) (time frame: Up to 1 year from the start of first TACE as a part of combination treatment). 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 NCT02311205, which also lists 7 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 18 Dec 2017.