Clinical trial · Interventional
A Study of the Effectiveness and Safety of AMG 386 and Sorafenib to Treat Advanced or Inoperable Hepatocellular Cancer
Phase 2 Open-label Multi-Center Study to Evaluate the Efficacy and Safety of AMG 386 and Sorafenib as First Line Therapy for Subjects With Advanced or Inoperable Hepatocellular Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether AMG 386, in combination with Sorafenib, is effective in the treatment of advanced or inoperable Hepatocellular cancer in subjects who have not received any prior systemic therapy except surgery or locoregional therapy. Disease status and disease progression will be assessed every 8 weeks. Subjects will remain on treatment until: progressive disease by RECIST criteria; clinical progression; death or loss to follow-up; or withdrawal of informed consent.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
| Inoperable Hepatocellular Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 386 | Drug | — | UNRESOLVED |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 15mg/ kg cohort
- description
- AMG 386 15mg/kg intravenously once weekly and Sorafenib 400mg orally twice daily in an every 4 weeks dosing schedule.
- interventionNames
- Drug: AMG 386
- Drug: Sorafenib
- type
- EXPERIMENTAL
- label
- 10 mg/kg cohort
- description
- AMG 386 10mg/kg intravenously once weekly and Sorafenib 400mg orally twice daily in an every 4 weeks dosing schedule.
- interventionNames
- Drug: AMG 386
- Drug: Sorafenib
Primary outcomes (1)
- measure
- Progression free survival (PFS) rate at 4 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed advanced or inoperable HCC * Child-Pugh A liver function score * Measurable disease with at least one unidimensionally measurable lesion per RECIST 1.0 guidelines with modifications * Adequate organ and hematological function * Men or women greater than or equal to 18 years old * Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less Exclusion Criteria: * Subject is eligible for a liver transplant per investigators discretion * Any previous systemic chemotherapy for HCC * History of arterial or venous thromboembolism within 12 months prior to enrollment * History of clinically significant bleeding within 6 months prior to enrollment * History of central nervous system metastases * Clinically significant cardiovascular disease within 12 months * Uncontrolled hypertension * Subjects with a history of prior malignancy
References
Publications (1)
- DERIVEDAbou-Alfa GK, Blanc JF, Miles S, Ganten T, Trojan J, Cebon J, Liem AK, Lipton L, Gupta C, Wu B, Bass M, Hollywood E, Ma J, Bradley M, Litten J, Saltz LB. Phase II Study of First-Line Trebananib Plus Sorafenib in Patients with Advanced Hepatocellular Carcinoma. Oncologist. 2017 Jul;22(7):780-e65. doi: 10.1634/theoncologist.2017-0058. Epub 2017 Jun 7. PMID 28592620