patients with hepatocellular carcinoma MedDRA version: 9.1 Level: LLT Classification code 10059319 Term: Hepatic cancer stage II
Conditions
Interventions
Trade Name: LEUKINE
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Sargramostim
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 500-
Sponsors
AZIENDA OSPEDALIERA DI PARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 50% evaluated by bidimensional US. Normal lung function (PaO2>90 mmHg, PaCO2=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed