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
- Conditions
- Neoplasms
- Registration Number
- KCT0007346
- Lead Sponsor
- Bundang CHA General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 10
•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).
•All lesions must not have been previously treated with TACE
•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* (see Appendix)
•Hb ? 9g/dL
•Absolute neutrophil count > 1500/mm3
•Platelet count ? 85x10^9/L
•Adequate clotting function: INR < 2
•Hepatic: AST and ALT < 5 X ULN
•Renal: serum creatinine < 1.5 x ULN
•Bilirubin < 2 mg/dL
•Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial
•The patient must give written, informed consent
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
•Hypertension defined as systolic blood pressure greater than 150 mmHg or diastolic pressure greater than 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 version 3.0)
•HIV infection or AIDS-related illness or serious acute or chronic illness (based on medical history)
•Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results
•Known or suspected allergy to the investigational agent or any agent given in association with this trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective tumor response, Progression free survival, Immune response
- Secondary Outcome Measures
Name Time Method aboratory test, Radiologic exam, EKG monitoring