Actively Recruiting
Cryoablation and Arterial Infusion of SD-101 in Combination With Durvalumab and Tremelimumab
Led by University of California, San Diego · Updated on 2026-04-30
20
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
T
TriSalus Life Sciences, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Cryoablation and Arterial Infusion of SD-101 in Combination With Durvalumab and Tremelimumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent before any study procedures
- Age 18 years or older
- Diagnosis of locally advanced, metastatic, or unresectable hepatocellular carcinoma confirmed by histology, cytology, or clinical criteria
- Tumor with a component at least 3 cm in size, located at least 1 cm from sensitive structures
- Not eligible for local therapies alone, such as liver transplantation or tumor ablation
- No prior systemic treatment for advanced or metastatic hepatocellular carcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least one measurable target lesion per RECIST v1.1 or mRECIST criteria
- Child-Pugh liver function class A or B7
- Life expectancy of 12 weeks or more
- Adequate bone marrow function with neutrophils ≥1000/mm³, platelets ≥50,000/mm³, and hemoglobin ≥8.0 g/dL
- Adequate kidney function with creatinine clearance ≥50 ml/min
- Adequate liver and pancreas function with bilirubin ≤2 times upper limit of normal, ALT or AST ≤5 times upper limit, and albumin ≥2 g/dL
- Adequate central nervous system function; seizure disorders allowed if well controlled with medication
- Systolic blood pressure below 160 mm Hg
- Use of effective contraception if of childbearing potential, including specific methods or agreement to abstinence
- Women able to become pregnant must have a negative pregnancy test at screening
You will not qualify if you...
- Brain metastases or spinal cord compression unless treated and stable for at least 4 weeks without steroids
- Severe or uncontrolled systemic diseases such as unstable respiratory or cardiac conditions
- Unresolved side effects from prior cancer therapy at grade 2 or higher (except hair loss) unless approved
- Significant heart problems including severe heart failure, recent heart attack, uncontrolled arrhythmias, or angina
- Participation in another investigational drug trial within 30 days
- Pregnant or breastfeeding women
- Large fluid accumulations in the abdomen or chest requiring frequent drainage
- Poorly controlled or severe hepatic encephalopathy
- History of organ or stem cell transplantation
- Previous pneumonitis or interstitial lung disease
- Receipt of live vaccines within 30 days
- Active or prior autoimmune or inflammatory diseases except certain stable or controlled conditions
- Use of immunosuppressive medications within 14 days before starting durvalumab except specific allowed steroids
- Any other condition judged by the investigator to make participation unsafe or non-compliant
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of California, San Diego
San Diego, California, United States, 92093
Actively Recruiting
Research Team
A
Adam Burgoyne, MD, PhD
CONTACT
G
Gastrointestinal Research Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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