Study in Asia of the Combination of TACE With Sorafenib in HCC Patients
START
START (Study in Asia of the Combination of Transcatheter Arterial Chemoembolization (TACE) With Sorafenib in Hepatocellular Carcinoma (HCC) Patients) Trial
1 other identifier
interventional
36
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hepatocellular-carcinoma
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 1, 2009
CompletedFirst Posted
Study publicly available on registry
October 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedJanuary 5, 2011
June 1, 2010
2 years
September 1, 2009
January 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability (such as adverse events and laboratory changes (haematology, clinical chemistry))
2 years
Secondary Outcomes (4)
Time to Progression
2 years
Overall survival
2 years
Progression Free Survival
2 years
No. of TACE cycles
2 years
Study Arms (1)
Sorafenib
EXPERIMENTALInterventions
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)
TACE (Transcatheter arterial chemoembolization)
Eligibility Criteria
You may qualify if:
- 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,
- +7 more criteria
You may not qualify if:
- 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.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
E-Da hospital
Kaohsiung City, 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
Related Publications (1)
Chao Y, Chung YH, Han G, Yoon JH, Yang J, Wang J, Shao GL, Kim BI, Lee TY. The combination of transcatheter arterial chemoembolization and sorafenib is well tolerated and effective in Asian patients with hepatocellular carcinoma: final results of the START trial. Int J Cancer. 2015 Mar 15;136(6):1458-67. doi: 10.1002/ijc.29126. Epub 2014 Sep 16.
PMID: 25099027DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yee Chao
VGH-TPE
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
September 1, 2009
First Posted
October 7, 2009
Study Start
February 1, 2009
Primary Completion
February 1, 2011
Last Updated
January 5, 2011
Record last verified: 2010-06