E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Unresectable primary hepatocellular carcinoma (pHCC) |
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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 | 10019828 |
E.1.2 | Term | Hepatocellular carcinoma non-resectable |
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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 |
Evaluation of health-related quality of life after radioembolization (RE) with SIR-Spheres versus Transarterial Chemoembolisation (TACE) in patients with unresectable, primary hepatocellular carcinoma. |
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E.2.2 | Secondary objectives of the trial |
Comparative evaluation of pharmaco-economic parameters and explorative comparison of safety and efficacy of RE and TACE |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with unresectable pHCC, diagnosis established according to EASL criteria, and - Liver function: Child-Pugh A - Performance status: ECOG < 2 - Tumour lesions: < 5 in number and < 20 cm in cumulative sum of maximum diameters - Life expectancy > 12 weeks |
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E.4 | Principal exclusion criteria |
(1) Patients expected to undergo surgery (resection or transplantation) within the 24-week period after randomization. (2) Ascites, detectable on physical examination or clinically symptomatic (3) Serum transaminases higher than 5 times the upper normal limit (4) Serum bilirubin > 2 mg/dL (5) Lung shunt > 15% (6) Extrahepatic disease (7) Moderate to severe portal hypertension (10) Impaired renal function (creatinine > 2 mg / dl) (11) Chemotherapy or other experimental therapy within preceding 4 weeks (12) Previous TAE / TACE (13) Previous radiation therapy to liver or lungs (14) Contraindications for angiography (severe peripheral vascular disease or uncorrectable bleeding diathesis) (15) Anatomical variants apparent on 99mTc-MAA scan precluding safe administration of RE (16) Any decompensated concomitant disease
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective of this trial is to assess health-related quality of life (HRQL) following RE or TACE at 3, 6, and 9 months following the first treatment with either modality (HRQL3M, HRQL6M, HRQL9M), using the FACT-Hep questionnaire. The primary endpoint, therefore, is the total FACT-Hep score per treatment group at 3, 6, and 9 months. |
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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 | Yes |
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 | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
health-related quality of life |
|
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |