Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
1,324actual
Sites
160
Countries
Brazil, Canada, China +14
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2017-10-11 | actual | When the study began enrolling |
| Primary completion | 2021-08-27 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2017-10-02 | actual | When this record first appeared on the registry |
| Results posted | 2023-06-18 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-27 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Hepatocellular Carcinoma
Interventions
- Drug: Durvalumab — also filed as MEDI4736
- Drug: Tremelimumab (Regimen 1)
- Drug: Tremelimumab (Regimen 2)
- Drug: Sorafenib
- Drug: Durvalumab (Regimen 1)
- Drug: Durvalumab (Regimen 2)
Primary outcome
what the primary-completion date above is the date OFOverall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg
measured From the date of randomization until death due to any cause, assessed up to the data cut-off date (27Aug2021, to a maximum of approximately 46 months).
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-06-17 · 11.6 MB · Prot_016.pdf
Statistical Analysis Planposted 2021-07-30 · 2.6 MB · SAP_018.pdf
Publications
- PMID 42108643 — linked by the registry
- PMID 41585428 — linked by the registry
- PMID 40222621 — linked by the registry
- PMID 39089633 — linked by the registry
- PMID 38805668 — linked by the registry
- PMID 38319892 — linked by the registry
- PMID 37678916 — linked by the registry
- PMID 37676259 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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