Study in Asia of the Combination of TACE With Sorafenib in HCC Patients

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taipei Veterans General Hospital, Taiwan
• Treatments: Doxorubicin; Liposomal doxorubicin; Sorafenib

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)