KCT0007346
Not yet recruiting
未知
Study to determine the safety and tolerability of combination therapy of TACE (Transarterial-chemoembolization) and Immunotherapy With the Autologous Killer Cell in patients with hepatocellular carcinoma: An open label study
Bundang CHA General Hospital0 sites10 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bundang CHA General Hospital
- Enrollment
- 10
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subjects ? 19 years of age
- •Patients with life expectancy of at least 12 weeks
- •Confirmed Diagnosis of HCC:
- •\- Cirrhotic subjects: Clinical diagnosis by AASLD criteria
- •\# HCC can be defined in cirrhotic subjects by one imaging technique (CT scan, MRI, or second generation contrast ultrasound) showing a nodule larger than 2cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behaviour for nodules of 1\-2cm in diameter
- •\# Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria
- •\- Documentation of original biopsy for diagnosis is acceptable
- •Child\-Pugh score \< 7 (Child A)
- •BCLC B (intermediate stage) i.e. multinodular asymptomatic tumours, without extraphepatic spread (but second branch invasion of the unilateral lobe is allowed) which are the usual group of patients amenable to have TACE performed.\* Bone scan and chest CT Test will be conducted to confirm without extrahepatic spread (mandatory for Korean sites only)
- •The patient must have a solitary hepatic tumour greater than 3 cm in diameter or multifocal disease as evidenced by CT or MRI scanning. This lesion can be measured accurately in at least 1 dimension according to RECIST (refer to Appendix for modified RECIST criteria).
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
Outcomes
Primary Outcomes
Not specified
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