CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 459 enrolled
Drug / intervention
Pexastimogene Devacirepvec (Pexa Vec) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02562755
NCT02562755Phase 3Completed
CompareCT.gov

A Phase 3 Randomized, Open-Label Study Comparing Pexa Vec (Vaccinia GM CSF / Thymidine Kinase-Deactivated Virus) Followed by Sorafenib Versus Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC) Without Prior Systemic Therapy

SillaJen, Inc.·interventional·Posted Sep 29, 2015·Updated Jun 8, 2026

In Brief

A Phase 3 clinical trial evaluating Pexastimogene Devacirepvec (Pexa Vec) and Sorafenib for Hepatocellular Carcinoma (HCC). Completed, enrolled 459 participants across 142 sites in 16 countries.

Detailed Summary

This is a randomized Phase 3 study to determine whether treatment with vaccinia virus based immunotherapy (Pexa-Vec) followed by sorafenib increases survival compared to treatment with sorafenib in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma (HCC)
CountriesAustralia, Canada, China, France, Germany, Hong Kong, Israel, Italy, New Zealand, Portugal, Singapore, South Korea, Taiwan, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 29, 2015
Enrollment StartOct 1, 2015
Primary CompletionJul 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 10.8 years ago

Interventions

Pexastimogene Devacirepvec (Pexa Vec)biological

Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells.

Sorafenibdrug

Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05. Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo. Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease.