Specific anti hepatocellular carcinoma dendritic cells implantation as therapy or adjuvant treatment for patients with advanced hepatocellular carcinoma.
Phase 2
- Conditions
- C22Malignant neoplasm of liver and intrahepatic bile ducts
- Registration Number
- DRKS00016606
- Lead Sponsor
- Faculty of medicine-Tanta University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
According to Barcelona Clinic Liver Cancer (BCLC) staging system, stage B HCC patients not fit for resection or local ablative therapies, stage C HCC patients with portal vein thrombosis and stage D HCC patients with lymphatic or distant metastases are included.
Exclusion Criteria
HCC patients (stage 0 and A) fit for radical or local ablation therapies or HCC patients with platelet count below 50,000 and or prothrombin activity below 50% were excluded from the study.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method What?<br>- Improvement in the clinical, laboratory and radiological characteristics of the tumour<br>How?<br>- Generation of dendritic cells from peripheral blood of each patient was performed. Dendritic cells were identified by CD 83, CD 86 expressions using flow cytometry. All patients included undergo a clinical, laboratory and radiological evaluation as Abdominal ultrasonography, and serum bilirubin, Alanine aminotransferase, Aspartate aminotransferase, albumin, International Normalized Ration, with estimation of the degree of ascites, encephalopathy and Child-Pugh Class<br>When?<br>- All of these clinical, laboratory and radiological investigations were performed before treatment (baseline) and after 1, 3 and 6 months of treatment (follow up).
- Secondary Outcome Measures
Name Time Method