New drug combo aims to fight untreatable liver cancer

NCT ID NCT05557838

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests a combination of two immunotherapy drugs, durvalumab and tremelimumab, as the first treatment for people with advanced liver cancer that cannot be removed by surgery. The study involves 214 Chinese patients and will measure safety, side effects, and how well the drugs control the cancer. The goal is to see if this drug pair can offer a better option for patients who have not had prior systemic therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: durvalumab and tremelimumab (immunotherapy drugs given by IV infusion)
What this could lead to: If successful, this combination could become a new first-line treatment option for Chinese patients with advanced liver cancer, potentially improving survival and tumor control.
What could go wrong: This is an open-label, single-country study with no placebo group, so results may be less definitive. Immunotherapy can cause serious immune-related side effects, and not all patients may respond.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

214 people

The number who actually took part.

Started

Feb 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria For inclusion in the study, patients should fulfill the following criteria: 1. Provide written informed consent to participate in the study before the start of the study 2. Age ≥18 years at the time of study entry. 3. Body weight \>30 kg. 4. Confirmed HCC based on histopathological findings from tumor tissue or radiologically findings. 5. Must not have received prior systemic therapy for HCC. 6. At least 1 measurable lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have a short axis ≥15 mm) with computerized tomography (CT) or magnetic resonance imaging (MRI), and that is suitable for accurate repeated measurements as per RECIST 1.1 guidelines. A lesion which progressed after previous ablation or TACE could be measurable if it meets these criteria. 7. Must not be eligible for locoregional therapy for unresectable HCC. For patients who progressed after locoregional therapy for HCC, locoregional therapy must have been completed ≥28 days prior to the baseline scan for the current study. 8. Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C. 9. Child-Pugh Score classification on liver disease and WHO/ECOG PS at enrolment must comply with one of the following criteria, not cumulatively: 1. Child-Pugh Score class A with WHO/ECOG PS 0-1 at enrolment will be enrolled in cohort1; 2. Child-Pugh class B with WHO/ECOG 0-1 will be enrolled in cohort 2; 3. Child-Pugh class A with WHO/ECOG 2 will be enrolled in cohort 2; Exclusion Criteria 1\) Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). 2）Previous study drug(s) assignment in the present study. 3）Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study. 4）Have received an investigational product within 28 days prior to the first dose of study drug(s). 5\) Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria: * Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis. * Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included (eg, hearing loss). 6\) Any concurrent chemotherapy, or biologic or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable. 7\) Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients. 8\) Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 28 days of the first dose of study drug(s). 9\) Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study drug(s). Note: Local surgery of isolated lesions for palliative intent is acceptable. 10\) History of allogeneic organ transplantation (eg, liver transplant). 11）History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy (eg, no lactulose, rifaximin, etc. if used for purposes of hepatic encephalopathy). 12\) Clinically meaningful ascites, defined as ascites requiring increasingly frequent non-pharmacologic intervention (eg, paracentesis) and/or escalation in pharmacologic intervention to maintain symptomatic control, within 2 months prior to the first scheduled dose. Subjects on stable doses of diuretics for ascites for ≥2 months are eligible. Also, uncontrolled pleural effusion, pericardial effusion requiring recurrent drainage procedures (once monthly or more frequently) . 13）Patients with main portal vein tumor thrombosis (Vp4). 14）Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 6 months.

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatocellular carcinoma

Contacts and locations

Locations

Research Site

Beijing, 100021, China
Research Site

Beijing, 100142, China
Research Site

Beijing, 211405, China
Research Site

Beijing, CN-100730, China
Research Site

Changsha, 410005, China
Research Site

Changsha, 410013, China
Research Site

Chengdu, 610041, China
Research Site

Fuzhou, 350011, China
Research Site

Guangzhou, 510060, China
Research Site

Guangzhou, 510100, China
Research Site

Guangzhou, 510260, China
Research Site

Guangzhou, 510515, China
Research Site

Hangzhou, 310022, China
Research Site

Harbin, 150081, China
Research Site

Jinan, 2501117, China
Research Site

Nanjing, 2100008, China
Research Site

Nanjing, 210009, China
Research Site

Nanjing, 210029, China
Research Site

Ningbo, 315010, China
Research Site

Shanghai, 200032, China
Research Site

Shanghai, 200040, China
Research Site

Shenyang, 110001, China
Research Site

Tianjin, 300000, China
Research Site

Wenzhou, 325000, China
Research Site

Wuhan, 430022, China
Research Site

Wuhan, 430079, China
Research Site

Xi'an, 710038, China
Research Site

Zhangjiagang, 215699, China
Research Site

Zhengzhou, 450008, China

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