Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (HCC)
NCT ID: NCT05883644
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
111 participants
INTERVENTIONAL
2023-06-27
2026-03-31
Brief Summary
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Detailed Description
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1. Child-Pugh score B7 or B8 with a World Health Organisation Eastern Cooperative Oncology Group Performance Status (WHO/ECOG PS) of 0-1 at enrolment, or
2. Child-Pugh class A with a WHO/ECOG PS of 2 at enrolment, or
3. Child-Pugh class A with a WHO/ECOG PS of 0-1 and with evidence of chronic main trunk portal vein thrombosis at enrolment
Participants must not have received any prior systemic therapy for HCC. Participants may have previously received locoregional therapy (LRT) but must no longer be suitable for additional LRT. Any local treatment needs to have been completed at least 4 weeks prior to initiation of treatment. The study consists of 4 periods: screening (Day-28 to Day -1), Treatment period, safety follow-up and survival follow-up.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Durvalumab plus Tremelimumab
Participants will receive a single priming dose of Tremelimumab plus Durvalumab at Day 1 (Week 0), followed by Durvalumab monotherapy starting at Week 4 and continuing until clinical progression, confirmed RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or any intervention discontinuation criteria.
Durvalumab
Participants will receive 1500 mg at Day 1 and later receive as monotherapy starting at Week 4 for every 4 weeks through IV infusion
Tremelimumab
Participants will receive single dose of 300 mg through IV infusion at Day 1
Interventions
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Durvalumab
Participants will receive 1500 mg at Day 1 and later receive as monotherapy starting at Week 4 for every 4 weeks through IV infusion
Tremelimumab
Participants will receive single dose of 300 mg through IV infusion at Day 1
Eligibility Criteria
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Inclusion Criteria
* Must not have received prior systemic therapy for HCC
* Participants expected to live 12 weeks or more
* At least 1 measurable lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter with CT or MRI, and that is suitable for accurate repeated measurements as per RECIST 1.1 guidelines
* Must not be eligible for LRT for unresectable HCC.
* Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy LRT) or stage C
* Child-Pugh Score classification on liver disease and WHO/ECOG PS at enrolment complying one of the following:
1. Child-Pugh score B7 or B8 with a WHO/ECOG PS of 0-1 at enrolment, without main trunk portal vein thrombosis.
2. Child-Pugh class A with a WHO/ECOG PS of 2 at enrolment, without main trunk portal vein thrombosis (ie, ECOG PS 2 participants with main portal vein tumour thrombosis are excluded from this study).
3. Child-Pugh class A with WHO/ECOG PS of 0-1 at enrolment and with chronic main trunk portal vein thrombosis
* Participants with hepatitis B virus (HBV) infection must be treated with antiviral therapy prior to enrolment.
* Participants with hepatitis C virus (HCV) infection must have confirmed diagnosis of HCV characterized by the presence of detectable HCV RNA or anti-HCV upon enrolment
* Adequate organ and bone marrow function
* Negative pregnancy test (serum) for women of childbearing potential.
* Female participants must be 1 year post-menopausal, surgically sterile, or using one highly effective form of birth control
* Male and Female participants and their partners must use an acceptable method of contraception.
* Body weight \>30 kg
Exclusion Criteria
* Refractory nausea and vomiting, chronic gastrointestinal (GI) disease, inability to swallow a formulated product, or previous significant bowel resection
* History of symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia
* History of another primary malignancy except for:
1. Malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence, or
2. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or lentigo maligna that has undergone potentially curative therapy, or
3. Adequately treated carcinoma in situ without evidence of disease
* Persistent toxicities (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade \> 1) caused by previous anticancer therapy
* Active or prior documented autoimmune or inflammatory disorders, autoimmune pneumonitis, and autoimmune myocarditis
* History of active primary immunodeficiency
* History of leptomeningeal carcinomatosis
* History of hepatic encephalopathy within the past 6 months or requirement for medications to prevent or control encephalopathy
* Active or prior documented GI bleeding (eg. esophageal varices or ulcer bleeding) within the past 6 months.
* Clinical judgement of acute main trunk portal vein thrombosis
* History of previous, or current, brain metastases or spinal cord compression
* Known fibrolamellar hepatocellular carcinoma (HCC), sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
* Clinically meaningful ascites
* Participants co-infected with HBV and HCV or co-infected with HBV and hepatitis D virus (HDV)
* Known to have tested positive for human immunodeficiency virus (HIV) or active tuberculosis infection
* Any concomitant medication known to be associated with Torsades de Pointes
* Prior exposure to immune-mediated therapy excluding therapeutic anticancer vaccines
* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab
* Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention" and "Major surgical procedure (as defined by the investigator) or significant traumatic injury within 4 weeks of the first dose of study intervention.
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen Chan, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Clinical Oncology, Chinese University of Hong Kong
Lorenza Rimassa, MD
Role: PRINCIPAL_INVESTIGATOR
Humanitas Cancer Centre, IRCCS Humanitas Research Hospital
Locations
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Research Site
La Jolla, California, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Detroit, Michigan, United States
Research Site
Bobigny, , France
Research Site
Clichy, , France
Research Site
Créteil, , France
Research Site
Marseille, , France
Research Site
Rennes, , France
Research Site
Berlin, , Germany
Research Site
Cologne, , Germany
Research Site
Frankfurt, , Germany
Research Site
Lübeck, , Germany
Research Site
Hong Kong, , Hong Kong
Research Site
Shatin, , Hong Kong
Research Site
Milan, , Italy
Research Site
Napoli, , Italy
Research Site
Padua, , Italy
Research Site
Pisa, , Italy
Research Site
Rozzano, , Italy
Research Site
Turin, , Italy
Research Site
Kanazawa, , Japan
Research Site
Kashiwa, , Japan
Research Site
Matsuyama, , Japan
Research Site
Musashino-shi, , Japan
Research Site
Osakasayama-shi, , Japan
Research Site
Yokohama, , Japan
Research Site
Singapore, , Singapore
Research Site
Singapore, , Singapore
Research Site
Singapore, , Singapore
Research Site
Gyeonggi-do, , South Korea
Research Site
Seongnam-si, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Barcelona, , Spain
Research Site
Córdoba, , Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Pamplona, , Spain
Research Site
Hanoi, , Vietnam
Countries
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Other Identifiers
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2022-502012-37-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D419CR00030
Identifier Type: -
Identifier Source: org_study_id
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