Sorafenib Combined With Transarterial Chemoembolization in Treating HBV-infected Patients With Intermediate Hepatocellular Carcinoma
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ClinicalTrials.gov Identifier: NCT01556815 |
Recruitment Status : Unknown
Verified April 2012 by Jinlong Song, Shandong Cancer Hospital and Institute.
Recruitment status was: Not yet recruiting
First Posted : March 16, 2012
Last Update Posted : April 25, 2012
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Condition or disease | Intervention/treatment | Phase |
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PHENYTOIN/SORAFENIB [VA Drug Interaction] Liver Neoplasms Carcinoma, Hepatocellular Digestive System Neoplasms Neoplasms by Site Liver Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type DOXORUBICIN/TRASTUZUMAB [VA Drug Interaction] HBV | Procedure: Transarterial Chemoembolization (TACE) Other: Sorafenib in combination with TACE | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Trail of Sorafenib Combined With Transarterial Chemoembolization in HBV-infected Patients With Intermediate Hepatocellular Carcinoma |
Study Start Date : | May 2012 |
Estimated Primary Completion Date : | May 2014 |
Estimated Study Completion Date : | May 2015 |

Arm | Intervention/treatment |
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Active Comparator: Group TACE
Patients who undergo TACE
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Procedure: Transarterial Chemoembolization (TACE)
Procedure:TACE TACE will be carried out with an emulsion of 50mg doxorubicin with lipiodol in a total volume of 10-20 mL; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated every 4 weeks for 2 cycles; additional cycles will be offered if clinically indicated . |
Experimental: Group Combination
Patients who are treated with sorafenib combined with TACE
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Other: Sorafenib in combination with TACE
Drug: Sorafenib All patients will receive Sorafenib (800 mg/day) p.o. beginning one week after the first TACE and every day thereafter until patient death or premature withdrawal from study. Procedure: TACE TACE will be carried out with an emulsion of 50mg doxorubicin with lipiodol in a total volume of 10-20 mL; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated every 4 weeks for 2 cycles; additional cycles will be offered if clinically indicated . Other Name: Sorafenib:Nexavar(brand name) |
- Effectiveness of sorafenib in increasing the effectiveness of transarterial chemoembolization (TACE) [ Time Frame: 1 year ]Measure:time-to-proression
- safety of sorafenib in combination with TACE [ Time Frame: 6 months ]Measure: incidence and grade of adverse events in patients treated with sorafenib combined with TACE (group B)
- Survival in the two treatment groups [ Time Frame: 2 years ]Measured from the date of TACE until the date of death or last visit

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients newly diagnosed as HCC according to European Association for Study of the Liver criteria.
- BCLC stage B
- Child-Pugh class A
- ECOG performance status of 0
- Etiology: Hepatitis B virus(HBV) infection
- Written informed consent (approved by the Institutional Review Board [IRB]obtained prior to any study specific screening procedures
- Patient must be able to comply with the protocol
- Age 18-80 years
- Haematology:Absolute neutrophil count (ANC) > 1 x 109/L, Platelet count > 40 x 109/L, Haemoglobin > 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin time international normalized ratio < 1.5
- Biochemistry:Total bilirubin < 2 mg/dL Serum creatinine < 1.5 x the upper limit of normal
- Life expectancy of > 3 months
Exclusion Criteria:
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 x the upper limit of normal
- Other severe concomitant disease that may reduce life expectancy
- uncontrolled hypertension
- Pregnancy (positive serum pregnancy test) or lactation
- Uncontrolled hypertension
- Serious, non-healing wound, ulcer, or bone fracture
- Currently or recent (within the 30 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational study
- Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents ( ≤ 6 months prior to study entry), myocardial infarction ( ≤ 6 months prior to study entry), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication
- Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of Sorafenib/TACE or patient at high risk from treatment complications

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556815
Contact: Jinlong Song, MD | +8653167626411 | songjlmd@gmail.com |
China, Shandong | |
Shandong Cancer Hospital and Institute | |
Jinan, Shandong, China, 250117 | |
Contact: Wenbo Shao, MD, Ph D +8653167626412 shaowenbomd@gmail.com | |
Principal Investigator: Jinlong Song, MD | |
Sub-Investigator: Wenbo Shao, MD, Ph D |
Principal Investigator: | Jinlong Song, MD | Shandong Cancer Hospital and Institute |
Responsible Party: | Jinlong Song, Chief, Division of Interventional Therapy, Shandong Cancer Hospital and Institute |
ClinicalTrials.gov Identifier: | NCT01556815 |
Other Study ID Numbers: |
ShandongCHI-001 |
First Posted: | March 16, 2012 Key Record Dates |
Last Update Posted: | April 25, 2012 |
Last Verified: | April 2012 |
Hepatocellular Carcinoma Sorafenib Transarterial Chemoembolization HBV |
Carcinoma Neoplasms Carcinoma, Hepatocellular Liver Neoplasms Neoplasms by Site Digestive System Neoplasms Gastrointestinal Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Liver Diseases Adenocarcinoma Digestive System Diseases Gastrointestinal Diseases |
Sorafenib Chlorotrianisene Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogens, Non-Steroidal Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal |