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First-line treatment for Chinese patients with advanced liver cancer using Durvalumab and Tremelimumab

An Open-label, Multi-center Phase IIIb Study of Durvalumab and Tremelimumab as First-Line Treatment in Patients With Unresectable Hepatocellular Carcinoma

PHASE3 · AstraZeneca · NCT05557838

This study is testing if a combination of two medications, Durvalumab and Tremelimumab, can be a safe and effective first treatment for Chinese patients with advanced liver cancer that can't be surgically removed.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment210 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca (industry)
Drugs / interventionsDruvalumab, Tremelimumab
Locations32 sites (Beijing and 31 other locations)
Trial IDNCT05557838 on ClinicalTrials.gov

What this trial studies

This interventional study evaluates the safety and efficacy of Durvalumab and Tremelimumab as a first-line treatment for Chinese patients diagnosed with unresectable hepatocellular carcinoma (HCC). It is a phase 3, open-label, multi-center trial that includes patients with specific eligibility criteria related to the stage of cancer and liver function. Participants will be assigned to different cohorts based on their Child-Pugh score and ECOG performance status, ensuring a tailored approach to treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are Chinese patients with unresectable hepatocellular carcinoma who have not received prior systemic therapy.

Not a fit: Patients with severe liver dysfunction, active gastrointestinal bleeding, or those with certain viral co-infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced liver cancer who currently have limited treatment choices.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy combinations in treating hepatocellular carcinoma, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Confirmed HCC based on histopathological findings from tumor tissue or radiologically findings
* No prior systemic therapy for HCC
* Barcelona Clinic Liver Cancer (BCLC) stage B (not eligible for locoregional therapy) or stage C
* Child-Pugh Score class A or B
* ECOG performance status (PS) of 0-2 at enrollment (Child-Pugh Score class A and ECOG PS of 0-1 will be enrolled in cohort 1 and Child-Pugh Score class B or ECOG PS of 2 will be enrolled in cohort 2)
* At least 1 measurable lesion per RECSIT 1.1 guidelines

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 6 months
* HBV and HVC co-infection, or HBV and Hep D co-infection

Where this trial is running

Beijing and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Hepatocellular Carcinoma

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.