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

January 3, 2011 updated by: Taipei Veterans General Hospital, Taiwan

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan
        • E-Da hospital
      • Kaoshiung, Taiwan
        • Veterans General Hospital- Kaochiung
      • Taichung, Taiwan
        • Veterans General Hospital- Taichung
      • Tainan, Taiwan
        • National Cheng Kung University Hospital
      • Taipei, Taiwan
        • MacKay Memorial Hospital
      • Taipei, Taiwan
        • Veterans General Hospital- Taipei
      • Taipei, Taiwan
        • Tri- Service General Hospital
      • TaoYuan Hsien, Taiwan
        • Chang-Gung Memorial Hospital- LinKou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability (such as adverse events and laboratory changes (haematology, clinical chemistry))
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 2 years
2 years
Progression Free Survival
Time Frame: 2 years
2 years
Time to Progression
Time Frame: 2 years
2 years
No. of TACE cycles
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Investigators

  • Principal Investigator: Yee Chao, VGH-TPE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ANTICIPATED)

February 1, 2011

Study Registration Dates

First Submitted

September 1, 2009

First Submitted That Met QC Criteria

October 6, 2009

First Posted (ESTIMATE)

October 7, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 5, 2011

Last Update Submitted That Met QC Criteria

January 3, 2011

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISS-13967

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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