RecruitingPhase 1NCT06710223

Cryoablation and Arterial Infusion of SD-101 in Combination With Durvalumab and Tremelimumab

A Phase Ib Study of Cryoablation and Pressure-enabled Hepatic Arterial Infusion of Class C Toll-like Receptor 9 Agonist SD-101 in Combination With Durvalumab and Tremelimumab in Patients With Advanced Hepatocellular Carcinoma


Sponsor

University of California, San Diego

Enrollment

20 participants

Start Date

Jan 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this Phase 1b clinical trial is to evaluate the safety and efficacy of cryoablation and hepatic arterial administration of SD-101 in participants with advanced hepatocellular carcinoma. After this procedure, participants will be treated with tremelimumab and durvalumab every 4 weeks (STRIDE regimen).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study combines a freezing procedure on liver tumors (cryoablation), an immune-stimulating injection (SD-101), and two immunotherapy drugs (durvalumab and tremelimumab) for people with liver cancer (hepatocellular carcinoma) that cannot be removed by surgery. **You may be eligible if...** - You are 18 or older - You have been diagnosed with locally advanced or metastatic liver cancer (hepatocellular carcinoma) confirmed by biopsy or standard imaging criteria - You have at least one liver tumor that is 3 cm or larger and positioned away from major blood vessels and bile ducts - You are in good overall health **You may NOT be eligible if...** - Your liver cancer has not been confirmed by the required diagnostic criteria - Your tumor is too close to vital structures for safe treatment - You have had certain prior systemic treatments that would disqualify you per the protocol 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSD-101

Toll-like receptor 9 (TLR9) agonist

DEVICECryotherapy

Cryoablation of liver

DRUGTremelimumab

Anti-CTLA4

DRUGDurvalumab

Anti-PDL1


Locations(1)

University of California, San Diego

San Diego, California, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06710223


Related Trials