Immunotherapy by autologous peripheral blood mononuclear cells and GM-CSF for hepatocellular carcinoma undergoing radiofrequency thermal ablation - HCC thermal ablation and immunotherapy combined treatment
- Conditions
- patients with hepatocellular carcinomaMedDRA version: 9.1Level: LLTClassification code 10059319Term: Hepatic cancer stage II
- Registration Number
- EUCTR2008-003925-17-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA DI PARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Multifocal HCC diagnosed by two concordant radiological examinations (US- CT scan) or by a single radiological examination and alpha-fetoprotein serum levels above 400 ng/ml, or histological diagnosis. Multifocal HCC with more than 3 liver nodules, 3 cm in diameter or total diameter of 2 nodules above 9 cm. Tumoral mass not exceeding 30% of the whole liver volume. Liver functionality evaluated according Child-Pugh score, within A5 and B8. Clinical conditions compatible with RF execution: Child-Pugh score as above defined, platelets >50.000/microL, prothrombin activity >50%, no severe portal hypertension (oesophageal varices > F2 or severe congestive gatropathy). Stage B according to Barcelona Clinic Liver Cancer Group (BCLC) staging system. That means HCC not suitable for curative treatments by liver resection or percutaneus ablative treatments and no symptoms and without a clear indication of chemoembolization (TAE or TACE) because of the multifocality of the tumor disease. Chronic HCV infection, HBsAg negative, ALT and AST <4 normal values. Peripheral lymphomonocytes above1500/microL. Normal renal function (creatinine <1.5 mg/dl). Heart function within normal values with ejection fraction >50% evaluated by bidimensional US. Normal lung function (PaO2>90 mmHg, PaCO2<42 mmHg). Age between 18 and 75. Patient capacity to understand informed consent. Geographical and logistic patient access to the medical center for a regular follow-up. Signed consent form.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Lack to fulfill the above described inclusion criteria Contraindication for RF treatment Less than 6 moths life expectancy Uncontrolled ongoing systemic infections Severe pharmacological intolerance (i.e. previous anaphylaxis) Pregnancy or breast feeding Severe immunosuppression or HIV infection Severe autoimmune disease undergoing immunosuppressive treatment Recent (last 3 months) or ongoing chemotherapy with the exception of the multikinase inhibitor sorafenib started by at least 3 month, without any significant toxic effect (CTC grade III and IV). Concomitant malignant neoplasia of different origin (with the exception of cutaneous basalioma) Any other clinical condition that could represent an impediment for enrolment as judged by the medical doctors involved in the study protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Feasibility and safety of a combined treatment consisting of RF and intralesional administration of autologous lymphomononuclear cells and GM-CSF for HCC patients not candidate for curative treatment;Secondary Objective: Evaluation of correlation between cell-mediated immune response and clinical response;Primary end point(s): Feasibility and safety of a combined treatment consisting of RF and intralesional administration of autologous lymphomononuclear cells and GM-CSF for HCC patients not candidate for curative treatment
- Secondary Outcome Measures
Name Time Method