SIRT With Tremelimumab and Durvalumab for Resectable HCC

Hepatocellular Carcinoma Clinical Trial

Official title: A Phase 1 Neoadjuvant Trial of Selective Internal Yttrium-90 Radioembolization (SIRT) With Tremelimumab and Durvalumab (MEDI4736) for Resectable Hepatocellular Carcinoma

Status Recruiting

Clinical Trial Summary

The goal of this research study is to evaluate the safety and tolerability of tremelimumab and durvalumab with or without Selective Internal Yttrium-90 Radioembolization (SIRT) in participants with resectable hepatocellular carcinoma (HCC) who will undergo liver surgery.

The names of the interventions involved in this study are:

• Durvalumab (a type of immunotherapy)

• Tremelimumab (a type of immunotherapy)

• Selective Internal Yttrium-90 Radioembolization (SIRT) (a type of radiation microsphere bead)

Clinical Trial Description

This is a Phase 1, open-label, randomized research study to evaluate the safety and tolerability of tremelimumab and durvalumab with or without Selective Internal Yttrium-90 Radioembolization (SIRT) in participants with resectable hepatocellular carcinoma (HCC) who will undergo liver surgery.

Participants will be randomized into one of two treatment groups: Durvalumab + Tremelimumab versus Durvalumab + Tremelimumab + SIRT. Randomization means that a participant is put into a group by chance. Radioembolization is a combination of radiation therapy and a procedure called embolization to treat cancer. SIRT blocks tumor blood supply by injecting radioactive particles into the hepatic artery and delivers internal radiotherapy on the tumor.

The U.S. Food and Drug Administration (FDA) has not approved Durvalumab as treatment for HCC but it has been approved for other uses.

The U.S. FDA has not approved tremelimumab as a treatment option for HCC.

The research study procedures include screening for eligibility, study treatment including evaluations, radiology scans of the liver, blood tests, electrocardiograms, and follow up visits.

Participation in this study is expected to last about 18 months with long-term follow up for a maximum of 3 years.

It is expected that about 20 people will take part in this research study.

AstraZeneca, a pharmaceutical company, is supplying the study drugs, tremelimumab and durvalumab. Sirtex Medical Inc., a medical device company, is supplying the Yttrium-90 resin Microsphere beads. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Cancer
• Hepatocellular Carcinoma
• Liver Neoplasms
• Resectable Hepatocellular Carcinoma

• NCT number: NCT05701488
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Contact: Jiping Wang, MD, PhD
• Phone: 617-732-8910
• Email: jwang39@partners.org
• Status: Recruiting
• Phase: Phase 1
• Start date: April 21, 2023
• Completion date: October 1, 2025