Study in Asia of the Combination of TACE With Sorafenib in HCC Patients
Overview[ - collapse ][ - ]
| Purpose | TACE possibly plays a significant role in contributing to a subgroup of surviving residual tumor tissue which is characterized by more aggressive biology. This explains the strong scientific rationale for exploring the role of anti-angiogenic therapy such as sorafenib to remedy and strengthen the therapeutic efficacy of TACE to combat liver cancers. Sorafenib plays a prominent auxiliary role by further suppressing the tumor growth and prolonging the time to recurrence and progression. Performing TACE under sorafenib administration may have synergic effect on hepatic tumoral lesions. |
|---|---|
| Condition | Hepatocellular Carcinoma |
| Intervention | Drug: doxorubicin Procedure: TACE (Transcatheter arterial chemoembolization) |
| Phase | Phase 2 |
| Sponsor | Taipei Veterans General Hospital, Taiwan |
| Responsible Party | Taipei Veterans General Hospital, Taiwan |
| ClinicalTrials.gov Identifier | NCT00990860 |
| First Received | September 1, 2009 |
| Last Updated | January 3, 2011 |
| Last verified | June 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 1, 2009 |
|---|---|
| Last Updated Date | January 3, 2011 |
| Start Date | February 2009 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Safety and tolerability (such as adverse events and laboratory changes (haematology, clinical chemistry)) [Time Frame: 2 years] [Designated as safety issue: Yes] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Study in Asia of the Combination of TACE With Sorafenib in HCC Patients |
|---|---|
| Official Title | START (Study in Asia of the Combination of Transcatheter Arterial Chemoembolization (TACE) With Sorafenib in Hepatocellular Carcinoma (HCC) Patients) Trial |
| Brief Summary | TACE possibly plays a significant role in contributing to a subgroup of surviving residual tumor tissue which is characterized by more aggressive biology. This explains the strong scientific rationale for exploring the role of anti-angiogenic therapy such as sorafenib to remedy and strengthen the therapeutic efficacy of TACE to combat liver cancers. Sorafenib plays a prominent auxiliary role by further suppressing the tumor growth and prolonging the time to recurrence and progression. Performing TACE under sorafenib administration may have synergic effect on hepatic tumoral lesions. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label |
| Condition | Hepatocellular Carcinoma |
| Intervention | Drug: doxorubicin After identifying the target artery of HCC, doxorubicin will be infused through the target artery of HCC patient with lipiodol emulsion (dependent on the tumor size) Procedure: TACE (Transcatheter arterial chemoembolization) TACE (Transcatheter arterial chemoembolization) |
| Study Arm (s) | Experimental: Sorafenib |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
|---|---|
| Estimated Enrollment | 36 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | February 2011 |
| Eligibility Criteria | Inclusion Criteria: - Age ≧ 18 - life expectancy > 12 weeks - Histologically diagnosed HCC, OR clinically diagnosed HCC for patients with difficulty in obtaining histological diagnosis. A clinically diagnosed HCC should fulfill ALL the criteria below - Chronic hepatitis B or C and/or evidence of liver cirrhosis. - Presence of hepatic tumour(s) with image findings compatible with HCC, and no evidence of other gastrointestinal tumours - A persistent elevation of serum AFP >= 400 ng/ml without any evidence of an existing α-fetoprotein-secreting germ cell tumour - Child-Pugh score ≦ 7 - BCLC B - The patient must have a solitary hepatic tumour greater than 3 cm in diameter or multifocal disease as evidenced by CT or MRI scanning. - The target lesion must not have been previously treated with local therapy - The patient must not be a candidate for surgical resection or ablation of the tumour. Size of largest tumor ≦10cm in largest dimension - Patients who have received previous local therapy treatments (RFA, PEI, cryoablation, surgery, resection) to non-target lesions are eligible - Local therapy must have been completed at least 4 weeks prior to baseline scan. - ECOG performance status 0 or 1 - Hb ≧ 9g/dL, - Absolute neutrophil count > 1000/mm3 - Platelet count ≧ 60x109/L - Adequate clotting function: INR < 1.5 - Hepatic: AST or ALT < 5 X ULN - Renal: serum creatinine < 1.5 x ULN - Bilirubin ≦ 3mg/dL - The patient must give written, informed consent Exclusion Criteria: - Tumor factors - Presence of extrahepatic metastasis - Predominantly infiltrative lesion - Diffuse tumor morphology with extensive lesions involving both lobes. - Vascular complications - Hepatic artery thrombosis, or - Partial or complete thrombosis of the main portal vein, or - Tumor invasion of portal branch of contralateral lobe, or - Hepatic vein tumor thrombus, or - Significant arterioportal shunt not amenable to shunt blockage - Liver function - Advanced liver disease: ascites, hepatic encephalopathy - Patients with clinically significant gastrointestinal bleeding within the 30 days prior to study entry. - Others - Pregnant or lactating women. - Active sepsis or bleeding. - Hypersensitivity to intravenous contrast agents. - The patient has received prior treatment for HCC target lesion. - History of cardiac disease - Congestive heart failure > NYHA class 2; active coronary artery disease - Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin. - Hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management. - Therapeutic anticoagulation with coumarin, heparins, or heparinoids. - Serious non-healing wounds (including wounds healing by secondary intention), acute or non-healing ulcers, or bone fractures within 3 months. - Impairment of swallowing that would preclude administration of sorafenib. - The patient is, in the opinion of the investigator, unable and / or unwilling to comply with treatment and study instructions. - Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted - Any active clinically serious infections (> grade 2 NCI-CTCAE ver 3.0) - HIV infection or AIDS-related illness or serious acute or chronic illness (based on medical history) |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Taiwan |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00990860 |
|---|---|
| Other Study ID Numbers | ISS-13967 |
| Has Data Monitoring Committee | No |
| Information Provided By | Taipei Veterans General Hospital, Taiwan |
| Study Sponsor | Taipei Veterans General Hospital, Taiwan |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Yee Chao VGH-TPE |
| Verification Date | June 2010 |
Locations[ + expand ][ + ]
| E-Da hospital | Kaohsiung, Taiwan |
|---|---|
| Veterans General Hospital- Kaochiung | Kaoshiung, Taiwan |
| Veterans General Hospital- Taichung | Taichung, Taiwan |
| National Cheng Kung University Hospital | Tainan, Taiwan |
| Veterans General Hospital- Taipei | Taipei, Taiwan |
| Mackay Memorial Hospital | Taipei, Taiwan |
| Tri- Service General Hospital | Taipei, Taiwan |
| Chang-Gung Memorial Hospital- LinKou | TaoYuan Hsien, Taiwan |