Authorised Therapeutic confirmatory (Phase III) Advanced hepatocellular carcinoma (HCC)

This is a randomized, open-label, multi-center, global, Phase III study to assess the effectiveness and safety of two Immune Therapy drugs, durvalumab given by itself or with tremelimumab versus sorafenib, the standard first line treatment, to treat patients with no prior systemic therapy for advanced liver cancer (hepatocellular carcinoma) that cannot be removed by surgery (unresectable).

EU CTIS ID: 2024-512212-21-00

What this study is testing

To assess the efficacy of durvalumab plus tremelimumab combination therapy compared with sorafenib.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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

You likely can't join if

  • Hepatic encephalopathy within past 12 months or requirement for medication to prevent or control encephalopathy - Clinical meaningful ascites - Main portal vein thrombosis - Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 12 months - HBV and HVC coinfection, or HBV and Hep D coinfection

The study team makes the final eligibility decision.

Where it's taking place

  • Hong Kong
  • Vietnam
  • United States
  • Ukraine
  • China
  • Canada
  • Taiwan
  • Japan
  • Brazil
  • India
  • Russian Federation
  • Thailand
  • Korea, Republic of

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Hong Kong; Vietnam; United States; Ukraine; China; Canada and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.