Active — Not RecruitingPhase 3

Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

United States1,324 participantsStarted 2017-10-11

Plain-language summary

This is a randomized, open-label, multi-center, global, Phase III study to assess the efficacy and safety of durvalumab plus tremelimumab combination therapy and durvalumab monotherapy versus sorafenib in the treatment of patients with no prior systemic therapy for unresectable HCC. The patients cannot be eligible for locoregional therapy

Who can participate

Age range18 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria * HCC based on histopathological confirmation * No prior systemic therapy for HCC * Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C * Child-Pugh Score class A * ECOG performance status of 0 or 1 at enrollment Exclusion criteria * Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy * Clinically meaningful ascites * Main portal vein tumor thrombosis * Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 12 months * HBV and HVC co-infection, or HBV and Hep D co-infection

What they're measuring

Overall Survival (OS) - Treme 300 mg x1 Dose + Durva 1500 mg vs Sora 400 mg

Timeframe: 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).

Trial details

NCT IDNCT03298451

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-08-27

Results submitted2022-08-26

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