Study in Asia of the Combination of TACE With Sorafenib in HCC Patients

Hepatocellular Carcinoma Clinical Trial

— START  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00990860
• Other study ID #: ISS-13967
• Secondary ID: ISS-13967
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 1, 2009
• Last updated: January 3, 2011
• Start date: February 2009

Study information

• Verified date: June 2010
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 a-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 Design

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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)

Locations

Country	Name	City	State
Taiwan	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

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability (such as adverse events and laboratory changes (haematology, clinical chemistry))		2 years	Yes
Secondary	Time to Progression		2 years	No
Secondary	Overall survival		2 years	No
Secondary	Progression Free Survival		2 years	No
Secondary	No. of TACE cycles		2 years	No