Status:
UNKNOWN
Study in Asia of the Combination of TACE With Sorafenib in HCC Patients
Lead Sponsor:
Taipei Veterans General Hospital, Taiwan
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00990860
Start Date
February 1 2009
Last Update
January 5 2011
Active Locations (8)
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1
E-Da hospital
Kaohsiung City, Taiwan
2
Veterans General Hospital- Kaochiung
Kaoshiung, Taiwan
3
Veterans General Hospital- Taichung
Taichung, Taiwan
4
National Cheng Kung University Hospital
Tainan, Taiwan