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

NCT06911255 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-05-14

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Tremelimumab Plus Durvalumab (MEDI4736)

Study subjects will receive 1,500 mg of durvalumab intravenously every 4 weeks until PD is observed. However, treatment will be discontinued if unacceptable toxicity, withdrawal of consent, or any other discontinuation criteria are met. Tremelimumab will be administered first, and durvalumab infusion will begin approximately 1 hour (up to 2 hours) after the completion of tremelimumab infusion. The standard infusion time for each drug is 1 hour, but if the infusion is temporarily interrupted, the total duration should not exceed 8 hours at room temperature.

PROCEDURE

Transarterial chemoembolization (TACE)

TACE will be carried out 1 to 2 weeks (7 to 14 days) after the administration of tremelimumab + durvalumab, and thereafter, it will be performed as needed at the discretion of the investigator during the treatment period. If additional TACE is performed, there must be at least a 1-week interval between the additional TACE and the administration of durvalumab.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Yoon Jun Kim

    lead OTHER

Principal Investigators

  • Yoon Jun Kim, MD, PhD · Seoul National University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-18
Primary Completion
2028-03-31
Completion
2028-06-30

Countries

  • South Korea

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06911255 on ClinicalTrials.gov