Study in Asia of the Combination of TACE With Sorafenib in HCC Patients (START)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00990860
Recruitment Status : Unknown
Verified June 2010 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was:  Active, not recruiting
First Posted : October 7, 2009
Last Update Posted : January 5, 2011
Information provided by:
Taipei Veterans General Hospital, Taiwan

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: doxorubicin Procedure: TACE (Transcatheter arterial chemoembolization) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: START (Study in Asia of the Combination of Transcatheter Arterial Chemoembolization (TACE) With Sorafenib in Hepatocellular Carcinoma (HCC) Patients) Trial
Study Start Date : February 2009
Estimated Primary Completion Date : February 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sorafenib 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)

Primary Outcome Measures :
  1. Safety and tolerability (such as adverse events and laboratory changes (haematology, clinical chemistry)) [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Time to Progression [ Time Frame: 2 years ]
  2. Overall survival [ Time Frame: 2 years ]
  3. Progression Free Survival [ Time Frame: 2 years ]
  4. No. of TACE cycles [ Time Frame: 2 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00990860

E-Da hospital
Kaohsiung, Taiwan
Veterans General Hospital- Kaochiung
Kaoshiung, Taiwan
Veterans General Hospital- Taichung
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Mackay Memorial Hospital
Taipei, Taiwan
Tri- Service General Hospital
Taipei, Taiwan
Veterans General Hospital- Taipei
Taipei, Taiwan
Chang-Gung Memorial Hospital- LinKou
TaoYuan Hsien, Taiwan
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Principal Investigator: Yee Chao VGH-TPE

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Yee Chao, Taipei Veterans General Hospital,Taiwan Identifier: NCT00990860     History of Changes
Other Study ID Numbers: ISS-13967
First Posted: October 7, 2009    Key Record Dates
Last Update Posted: January 5, 2011
Last Verified: June 2010

Keywords provided by Taipei Veterans General Hospital, Taiwan:
Combination of TACE With Sorafenib

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors