NCT07489976

IIT2025-03-YANG-LIFT-HCC

Leveraging Immunotherapy For Tumor Downstaging to Milan Criteria in Patients With Hepatocellular Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: Ju Dong Yang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators are doing this study to learn if a combination of immunotherapy and a liver-directed tumor procedure can safely and effectively shrink or control liver cancer (hepatocellular carcinoma, HCC). The goal is to try to lower the stage of the cancer so that more patients may become eligible for a liver transplant. The investigators will also closely watch for side effects from the study treatments. Section 2 has more details.

Detailed description

The investigators are doing this study to learn if a combination of immunotherapy and a liver-directed tumor procedure can safely and effectively shrink or control liver cancer (hepatocellular carcinoma, HCC). The goal is to try to lower the stage of the cancer so that more patients may become eligible for a liver transplant. The investigators will also closely watch for side effects from the study treatments. What are the study treatments? The patients will receive immunotherapy medicines through a vein (IV). The first treatment is a combination of tremelimumab and durvalumab, called STRIDE. After that, the patients may continue durvalumab about once every 4 weeks up to total of 12 cycles on study. The patients will also have a liver-directed tumor treatment (LRT), which is a procedure to treat the tumor inside the liver. Depending on what is best for the patients, this may include Yttrium-90 (Y90) (radiation delivered inside the liver), TACE (chemotherapy delivered directly to the liver tumor through a small tube placed in a blood vessel), or RFA (heat used to destroy the tumor). These procedures are done by a specialist using imaging guidance, and the patients may receive medicine to help the patients relax or sleep. The patients will be monitored during and after the procedure. The patients are being asked to take part in this research study because the patients have intermediate or advanced hepatocellular carcinoma (HCC). The U.S. Food and Drug Administration (FDA) has approved those drugs as they are being used in this study. Another purpose of this study is for researchers to learn if a biomarker test is helpful in determining long-term effects of ICI. A biomarker is a biological molecule found in blood, other body fluids or tissues. Biomarkers may be a sign of a condition or disease. Biomarkers also can be used to predict patient's response to a specific treatment. The study will include up to 41 patients total.

Conditions

• Hepato Cellular Carcinoma

Interventions

Type	Name	Description
DRUG	STRIDE Regimen (Tremelimumab 300 mg AND Durvalumab 1500 mg) combined with LRT (TACE, TARE, or RFA)	• To assess the success rate of combining ICIs and LRT (as neoadjuvant treatment) in tumor downstaging to Milan Criteria within 12 months of baseline STRIDE treatment in patients with HCC exceeding the University of California San Francisco (UCSF) criteria.

Timeline

• Start date: 2026-04-01
• Primary completion: 2030-04-01
• Completion: 2030-12-31
• First posted: 2026-03-24
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study