RecruitingPhase 1Phase 2NCT06911255

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

Sponsor

Yoon Jun Kim

Enrollment

24 participants

Start Date

Apr 18, 2025

Study Type

INTERVENTIONAL

Conditions

Unresectable Hepatocellular Carcinoma Hepatocellular Carcinoma (HCC)

Summary

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

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of immunotherapy drugs (tremelimumab and durvalumab) given alongside a liver procedure called TACE (a treatment that delivers chemotherapy directly into liver tumors and cuts off their blood supply) for people with liver cancer that cannot be surgically removed. **You may be eligible if...** - You are 19 or older - You have been diagnosed with hepatocellular carcinoma (liver cancer) confirmed by biopsy or imaging - Your liver cancer is at an intermediate or advanced stage and has not spread to more than one other organ, with no more than 5 spots elsewhere - At least one tumor in your liver has not been treated before - Your liver is functioning well enough (Child-Pugh class A) - You are physically active and able to care for yourself - Your blood counts, liver, and kidney values are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread widely outside the liver - You have uncontrolled HIV, hepatitis B with high viral levels, or untreated hepatitis C - You have another active cancer - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTremelimumab 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.

PROCEDURETransarterial 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.