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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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (8 locations)

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