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Safety and Efficacy of Tremelimumab+Durvalumab(MEDI4736)+TACE in Unresectable Hepatocellular Carcinoma | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

Safety and Efficacy of Tremelimumab+Durvalumab(MEDI4736)+TACE in Unresectable Hepatocellular Carcinoma

A Phase I/IIa, Single-arm, Open-label, IIT for Safety and Efficacy Evaluation of Tremelimumab Plus Durvalumab(MEDI4736) in Combination With Concurrent Transarterial Chemoembolization in Unresectable Hepatocellular Carcinoma

NCT06911255•Yoon Jun Kim

View on ClinicalTrials.gov

Summary

Safety and Efficacy Evaluation of Tremelimumab Plus Durvalumab(MEDI4736) in Combination with Concurrent Transarterial Chemoembolization in Unresectable Hepatocellular carcinoma

Detailed Description

The purpose of this clinical trial is to evaluate the safety and efficacy of tremelimumab + durvalumab administered concurrently with transarterial chemoembolization (TACE) in patients diagnosed with hepatocellular carcinoma (HCC) who are not eligible for curative liver resection. Primary Objective: The primary objective of this clinical trial is to evaluate progression-free survival (PFS) from the time of registration using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Secondary Objectives: Overall Survival (OS): To assess the overall survival from the first dose of the study drug until the data cutoff point, as determined by the investigator. Objective Response Rate (ORR): To assess the objective response rate of target and non-target lesions using mRECIST and RECIST 1.1. Evaluations will occur every 8 weeks after 12 weeks and for the first 48 weeks from the time of registration, and then every 12 weeks thereafter. Time to Progression (TTP): To measure the time from registration to disease progression using mRECIST and RECIST 1.1. Safety Evaluation: To evaluate the safety of tremelimumab and durvalumab, including adverse events, vital signs (blood pressure and pulse rate), and laboratory safety assessments (clinical chemistry, hematology, etc.), by assessing changes from baseline.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
•2\. Male or female, aged ≥19 years at time of study entry. 3. Diagnosed with unequivocal HCC confirmed histologically or diagnosed radiologically according to American Association for the Study of Liver Diseases practice guideline.
•4\. Barcelona clinic liver cancer (BCLC) staging intermediate (B) stage or BCLC advanced stage (C) HCC with or without minimal extrahepatic disease (single-organ metastasis, ≤5 metastatic lesions).
•5\. Must have at least 1 untreated measurable disease (untreated target lesion i.e. a viable lesion that has never been treated with locoregional treatment \[transarterial chemoembolization {TACE}, TARE, percutaneous ethanol injection therapy, or radiofrequency ablation\]).
•6\. Child-Pugh score 5 or 6 points (Child-Pugh class A). 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 8. Life expectancy of ≥ 12 weeks. 9. Body weight \>30 kg. 10. Adequate normal organ and marrow function as defined below:
•Hemoglobin ≥9.0 g/dL
•Absolute neutrophil count (ANC) ≥1500 per mm3
•Platelet count ≥75,000 per mm3
•Albumin ≥2.8 g/dL
•Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). (This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with the Investigator).
+36 more criteria

Exclusion Criteria

•1\. Eligible for potentially curative treatment (surgical resection, radiofrequency ablation or immediate liver transplantation).
•2\. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti- Cytotoxic T-lymphocyte- associated antigen-4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune pathways, including prior randomization or treatment in a previous durvalumab and/or tremelimumab clinical study regardless of treatment arm assignment.
•3\. History of organ transplantation or hematopoietic stem cell transplantation.
•4\. Any other concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, papillary thyroid cancer, early gastric cancer, or other cancer for which the patient has been disease-free for at least five years.
•5\. A history of a severe contrast allergy (i.e. anaphylaxis) not controlled with premedication.
•6\. Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product (IP) or interpretation of patient safety or study results.
•7\. Participation in another clinical study with an IP during the last 8 weeks or 5 half-lives of the study drug, whichever is longer, prior to screening.
•8\. Concurrent enrolment in another clinical study, unless it is an observational (non- interventional) clinical study or during the follow-up period of an interventional study.
•9\. Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) ≤1 cycle length or 14 days, whichever is longer, prior to the first dose of study drug. If sufficient wash-out time has not occurred due to the schedule or PK properties of an agent, a longer wash-out period will be required, as determined by the Investigator.

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Key Dates

Start Date

April 18, 2025

Primary Completion Date

March 31, 2028

Completion Date

June 30, 2028

Last Updated

May 14, 2025

Enrollment

ESTIMATED participants

Conditions

Hepatocellular Carcinoma (HCC)Unresectable Hepatocellular Carcinoma

Interventions

Tremelimumab Plus Durvalumab (MEDI4736)

DRUG

Transarterial chemoembolization (TACE)

PROCEDURE

Contacts

Yoon Jun Kim, MD, PhD

CONTACT

82-2-2072-3081 yoonjun@snu.ac.kr

Yun Bin Lee, MD, PhD

CONTACT

82-2-2072-2228 yblee@snu.ac.kr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy of Tremelimumab+Durvalumab(MEDI4736)+TACE in Unresectable Hepatocellular Carcinoma

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)

NIS on the Benefits of TIPS in Patients With HCC Receiving Atezo+Bev in 1st-Line Therapy

The Treatment of Liver Injury After Liver Resection With Polyene Phosphatidylcholine

A Two-Arm, Multicenter, Non-Randomized Controlled Study on the Efficacy of Yttrium-90 (Selective Internal Radiation Therapy) Therapy and Hepatic Arterial Infusion Chemotherapy (Hepatic Artery Infusion Chemotherapy) for Potentially Resectable Intermediate and Advanced Hepatocellular Carcinoma

Lenvatinib Plus Tislelizumab Versus Lenvatinib Alone in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab

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