E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
advanced hepatocellular carcinoma (HCC) with portal vein thrombosis |
|
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 | 10024662 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10019713 |
|
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 |
1. radiological tumor response according to RECIST modified, WHO modified-EASL and Choi criteria and laboratory response (alpha-fetoprotein level). |
|
E.2.2 | Secondary objectives of the trial |
1. time to progression of disease in the liver and any other site (TTP) 2. time to symptomatic progression of disease (TTSP) assessed by FHSI-8 questionnaire 3. time to untreatable progression (TTUP) 4. toxicity assessed by CTCAE criteria 5. survival from the time of treatment with TheraSphere 6. quality of life assessed by FACT-Hep questionnaire |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Diagnosis of HCC: based on the Guidelines issued by EASL and AASLD criteria (latest diagnostic radiological imaging performed within 1 month from enrollment) 2. HCC for which transplantation, surgical resection or percutaneous ablation are not indicated 3. Portal vein thrombosis (segmental or lobar branch and common portal trunk) 4. Tumor volume  50% of whole liver 5. Child-Pugh class A-B7 6. Performance status: ECOG 0-2 (WHO) 7. Target liver lesion measurable 8. Life expectancy of at least 3 months in absence of treatments 9. The following laboratory parameters must be met: Creatinine ≤ 1.50 mg/dL Bilirubin  2 mg/dL Albumin  3 g/dL White blood cells 1.5 x 109/L PLT  50 x 109/L PT  50% 10. Signature of informed consent obtained |
|
E.4 | Principal exclusion criteria |
1. Liver tumor undefined, unmeasurable or not assessable 2. Uncontrolled ascites, F3-type varices 3. Contraindications to arteriography 4. Presence of hemodynamically relevant abnormalities of hepatic arterial structure, such as not to allow for a correct and safe delivery of microspheres 5. Presence of hepato-pulmonary shunt percentage potentially for >30 Gy exposure to lungs 6. Presence of chronic or acute co-morbidities (to lungs, heart, kidneys or brain) because of which the patient is not eligible to receive the treatment foreseen by the protocol. 7. Prior tumors in the 5 preceding years or concomitance of other tumors at enrollment, with the exception of cutaneous basal cell or squamous cells carcinoma or carcinoma in situ of the uterine cervix 8. Presence of localized or systemic infections (with the exception of HIV infection responsive to therapy) 9. Pregnant women (women of child-bearing potential will have a pregnancy test done) and breastfeeding women 10. Age under 18 years 11. Known or suspect hypersensitivity to the investigational drug or to the investigational pharmacological class 12. Patients presenting with severe clinical conditions which in the opinion of the investigator contraindicate patient participation in the study 13. Use of investigational drugs in the last month prior to inclusion into the study 14. Patients who are not capable of complying with the procedures established by the protocol and of signing the informed consent. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of the study is to access: 1. radiological tumor response according to RECIST modified, WHO modified-EASL and Choi criteria and laboratory response (alpha-fetoprotein level). |
|
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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
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
|
Last Patient Last Visit= Last Patient Last Follow-up Visit |
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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 | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |