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START (Study in Asia of the Combination of Transcatheter Arterial Chemoembolization (TACE) With Sorafenib in Hepatocellular Carcinoma (HCC) Patients) Trial


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

START (Study in Asia of the Combination of Transcatheter Arterial Chemoembolization (TACE) With Sorafenib in Hepatocellular Carcinoma (HCC) Patients) Trial


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Safety and tolerability (such as adverse events and laboratory changes (haematology, clinical chemistry))

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Yee Chao

Investigator Role:

Principal Investigator

Investigator Affiliation:

VGH-TPE

Authority:

Taiwan: Institutional Review Board

Study ID:

ISS-13967

NCT ID:

NCT00990860

Start Date:

February 2009

Completion Date:

Related Keywords:

  • Hepatocellular Carcinoma
  • Combination of TACE With Sorafenib
  • Carcinoma
  • Carcinoma, Hepatocellular

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