Trials / Completed
CompletedNCT02562755
Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 459 (actual)
- Sponsor
- SillaJen, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This is a multi-center, randomized, open-label, Phase 3 study comparing Pexa Vec followed by sorafenib versus sorafenib in patients with advanced HCC without prior systemic therapy. A total of 459 patients were randomly assigned to 2 treatment arms- 234 patients in the Pexa-Vec followed by sorafenib treatment group and 225 patients in the sorafenib only treatment group.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pexastimogene Devacirepvec (Pexa Vec) | Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells. |
| DRUG | Sorafenib | 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. |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2020-07-01
- Completion
- 2020-07-01
- First posted
- 2015-09-29
- Last updated
- 2020-12-16
- Results posted
- 2020-12-16
Locations
142 sites across 16 countries: United States, Australia, Canada, China, France, Germany, Hong Kong, Israel, Italy, New Zealand, Portugal, Singapore, South Korea, Taiwan, Thailand, United Kingdom
Source: ClinicalTrials.gov record NCT02562755. Inclusion in this directory is not an endorsement.