Trial record 17 of 363 for:
Open Studies | "Carcinoma, Hepatocellular"
Sorafenib Combined With Transarterial Chemoembolization in Treating HBV-infected Patients With Intermediate Hepatocellular Carcinoma
This study is not yet open for participant recruitment.
Verified April 2012 by Shandong Cancer Hospital and Institute
Sponsor:
Shandong Cancer Hospital and Institute
Information provided by (Responsible Party):
Jinlong Song, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier:
NCT01556815
First received: March 14, 2012
Last updated: April 24, 2012
Last verified: April 2012
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Purpose
Transarterial chemoembolization (TACE) is widely used for unresectable hepatocellular carcinoma (HCC). However, the hypoxia caused by TACE in surviving tumor cell leads to release of angiogenic and growth factors contributing to poor outcome. Sorafenib can block tumor cell proliferation and angiogenesis. The hypothesis is that patients with unresectable HCC may benefit from sorafenib in combination with TACE.
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trail of Sorafenib Combined With Transarterial Chemoembolization in HBV-infected Patients With Intermediate Hepatocellular Carcinoma |
Resource links provided by NLM:
Further study details as provided by Shandong Cancer Hospital and Institute:
Primary Outcome Measures:
- Effectiveness of sorafenib in increasing the effectiveness of transarterial chemoembolization (TACE) [ Time Frame: 1 year ] [ Designated as safety issue: No ]Measure:time-to-proression
Secondary Outcome Measures:
- safety of sorafenib in combination with TACE [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]Measured from the date of TACE until the date of death or last visit
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group TACE
Patients who undergo TACE
|
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
|
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)
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556815
Contacts
| Contact: Jinlong Song, MD | +8653167626411 | songjlmd@gmail.com |
Locations
| China, Shandong | |
| Shandong Cancer Hospital and Institute | Not yet recruiting |
| 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 | |
Sponsors and Collaborators
Shandong Cancer Hospital and Institute
Investigators
| Principal Investigator: | Jinlong Song, MD | Shandong Cancer Hospital and Institute |
More Information
No publications provided
| Responsible Party: | Jinlong Song, Chief, Division of Interventional Therapy, Shandong Cancer Hospital and Institute |
| ClinicalTrials.gov Identifier: | NCT01556815 History of Changes |
| Other Study ID Numbers: | ShandongCHI-001 |
| Study First Received: | March 14, 2012 |
| Last Updated: | April 24, 2012 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Shandong Cancer Hospital and Institute:
|
Hepatocellular Carcinoma Sorafenib Transarterial Chemoembolization HBV |
Additional relevant MeSH terms:
|
Carcinoma, Hepatocellular Adenocarcinoma Adenocarcinoma, Mucinous Neoplasms Carcinoma Digestive System Neoplasms Gastrointestinal Neoplasms Liver Diseases Liver Neoplasms Neoplasms by Histologic Type Neoplasms by Site |
Neoplasms, Glandular and Epithelial Neoplasms, Cystic, Mucinous, and Serous Digestive System Diseases Gastrointestinal Diseases Sorafenib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013