A prospective randomized clinical trial with the medical device Therasphere versus the drug sorafenib for the treatment of liver cancer (Hcc) with a clot in the major liver (Portal Vein Thrombosis - PVT)

Phase 1

• Conditions: Advanced Hepatocellular Carcinoma (HCC) with Portal Vein Thrombosis (PVT); MedDRA version: 16.0Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 100000004864; MedDRA version: 16.0Level: PTClassification code 10036206Term: Portal vein thrombosisSystem Organ Class: 10019805 - Hepatobiliary disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-005375-14-ES
• Lead Sponsor: ordion (Canada) Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-10
• Last Update Posted: 21 July 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 328

Inclusion Criteria

- Patients over 18 years of age, regardless of race or gender
- Advanced stage HCC with PVT and no extrahepatic metastases
- Child-Pugh A
- ECOG 0-1
- No contraindication to study treatment or procedures
- Not eligible for curative treatment including liver transplant
- No prior external beam radiation therapy
- No previous treatment with Sorafenib for more than 4 weeks during the 2 previous months; no prior sorafenib-related toxicity
- No previous conventional or drug eluting TACE unless it was performed at least 6 months prior to screening phase
- No history of organ allograft
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 164
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 164

Exclusion Criteria

Not applicable

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified