NCT05701488

SIRT With Tremelimumab and Durvalumab for Resectable HCC

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Jiping Wang, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed 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.

Conditions

• Resectable Hepatocellular Carcinoma
• Hepatocellular Carcinoma
• Hepatocellular Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	Intravenous infusion
DRUG	Tremelimumab	Intravenous infusion
DEVICE	SIRT	SIR (Selective Internal Radiation) Sphere resin microspheres, radioactive particles delivered via injection into an artery.

Timeline

• Start date: 2023-04-21
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2023-01-27
• Last updated: 2025-09-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study