E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with hepatocellular carcinoma |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059319 |
E.1.2 | Term | Hepatic cancer stage II |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
|
E.2.2 | Secondary objectives of the trial |
Evaluation of correlation between cell-mediated immune response and clinical response |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 <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. |
|
E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |