A Phase 3 interventional study of Pexastimogene Devacirepvec (Pexa Vec) and Sorafenib in Hepatocellular Carcinoma (HCC), sponsored by SillaJen, Inc.. Completed at 142 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by SillaJen, Inc. · Phase 3, Interventional, and Treatment
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.
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.
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.
This study's enrollment of 459 is above the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →SillaJen, Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pexa-Vec (pexastimogene devacirepvec) will be administered as 3 bi-weekly intratumoral (IT) injections of 1e9 pfu at day 1 and weeks 2 and 4, followed by sorafenib at Week 6.
Biological: Pexastimogene Devacirepvec (Pexa Vec) · Drug: Sorafenib
Sorafenib (400 mg twice daily) begins on Day 1.
Drug: Sorafenib
Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells.
Also known as: JX-594
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.
Also known as: Nexavar
Overall Response Rate (ORR)
Percentage of participants who showed overall response during their participation in the study. Per Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) and assessed by tri-phasic contrast enhanced CT: Complete Response (CR), Disappearance of intratumoral enhancing area; Partial Response (PR), \>=30% decrease in the sum of the diameters of enhancing area; Overall Response (OR) = CR + PR.
Time frame: From date of randomization to the date of first documented radiographic tumor progression up to 53 months
| Milestone | Pexa-Vec Followed by Sorafenib | Sorafenib |
|---|---|---|
| Started | 234 | 225 |
| Safety population | 218 | 217 |
| Completed | 161 | 153 |
| Not completed | 73 | 72 |
Percentage of participants who showed overall response during their participation in the study. Per Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) and assessed by tri-phasic contrast enhanced CT: Complete Response (CR), Disappearance of intratumoral enhancing area; Partial Response (PR), \>=30% decrease in the sum of the diameters of enhancing area; Overall Response (OR) = CR + PR.
| percentage of participants | Pexa-Vec Followed by Sorafenib | Sorafenib |
|---|---|---|
| Overall Response Rate (ORR) | 19.2 | 20.9 |
Collected over From date of randomization to end of participation in the study, up to 53 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pexa-Vec Followed by Sorafenib | 33/218 (15.1%) | 117/218 (53.7%) | 218/218 (100%) |
| Sorafenib | 25/217 (11.5%) | 77/217 (35.5%) | 214/217 (98.6%) |
| Event | Pexa-Vec Followed by Sorafenib | Sorafenib |
|---|---|---|
| Hepatic failureHepatobiliary disorders | 11/218 | 8/217 |
| PyrexiaGeneral disorders | 8/218 | 1/217 |
| AscitesGastrointestinal disorders | 8/218 | 4/217 |
| Abdominal pain upperGastrointestinal disorders | 7/218 | 3/217 |
| AstheniaGeneral disorders | 3/218 | 5/217 |
| Abdominal painGastrointestinal disorders | 4/218 | 5/217 |
| Hepatic encephalopathyNervous system disorders | 5/218 | 4/217 |
| Neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 4/218 | 4/217 |
| Blood bilirubin increasedInjury, poisoning and procedural complications | 1/218 | 4/217 |
| PneumoniaInfections and infestations | 3/218 | 4/217 |
| Event | Pexa-Vec Followed by Sorafenib | Sorafenib |
|---|---|---|
| PyrexiaGeneral disorders | 184/218 | 28/217 |
| DiarrhoeaGastrointestinal disorders | 107/218 | 116/217 |
| Palmar plantar erythrodysaesthesia syndromeSkin and subcutaneous tissue disorders | 73/218 | 99/217 |
| Decreased appetiteMetabolism and nutrition disorders | 85/218 | 64/217 |
| NauseaGastrointestinal disorders | 74/218 | 63/217 |
| ChillsGeneral disorders | 71/218 | 4/217 |
| FatigueGeneral disorders | 65/218 | 64/217 |
| Abdominal painGastrointestinal disorders | 62/218 | 60/217 |
| Weight decreasedInvestigations | 58/218 | 49/217 |
| VomitingGastrointestinal disorders | 56/218 | 27/217 |
| Age, Categorical(Participants) | Pexa-Vec Followed by Sorafenib | Sorafenib | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 133 | 148 | 281 |
| >=65 years | 101 | 77 | 178 |
| Age, Continuous(years) | Pexa-Vec Followed by Sorafenib | Sorafenib | Total |
|---|---|---|---|
| Mean | 61.3 ± 10.05 | 60.5 ± 11.06 | 60.9 ± 10.55 |
| Sex: Female, Male(Participants) | Pexa-Vec Followed by Sorafenib | Sorafenib | Total |
|---|---|---|---|
| Female | 30 | 43 | 73 |
| Male | 204 | 182 | 386 |
| Ethnicity (NIH/OMB)(Participants) | Pexa-Vec Followed by Sorafenib | Sorafenib | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 6 | 11 |
| Not Hispanic or Latino | 229 | 219 | 448 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Pexa-Vec Followed by Sorafenib | Sorafenib | Total |
|---|---|---|---|
| Singapore | 8 | 3 | 11 |
| Hong Kong | 1 | 3 | 4 |
| United States | 40 | 34 | 74 |
| United Kingdom | 3 | 4 | 7 |
| Thailand | 2 | 5 | 7 |
| Portugal | 2 | 3 | 5 |
| New Zealand | 27 | 27 | 54 |
| Canada | 5 | 4 | 9 |
| South Korea | 61 | 68 | 129 |
| China | 42 | 40 | 82 |
| Taiwan | 13 | 10 | 23 |
| Italy | 1 | 3 | 4 |
| Israel | 1 | 2 | 3 |
| Australia | 9 | 5 | 14 |
| France | 12 | 8 | 20 |
| Germany | 7 | 6 | 13 |
| ECOG performance status(Participants) | Pexa-Vec Followed by Sorafenib | Sorafenib | Total |
|---|---|---|---|
| 0 | 146 | 142 | 288 |
| 1 | 88 | 83 | 171 |
Showing the first 100 of 142 sites across 16 countries.
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