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Cryoablation and SD-101 with Durvalumab and Tremelimumab for Liver Cancer

This Phase 1b clinical trial is testing a new approach for advanced hepatocellular carcinoma (liver cancer). It combines cryoablation (freezing the tumor) and an injection of SD-101 directly into the liver artery. SD-101 is a drug that helps activate your immune system to fight cancer. After this procedure, participants will receive two immunotherapy drugs, tremelimumab and durvalumab, every four weeks. The main goal is to see how safe this combination treatment is, measured by any side effects over six months. You may be able to join if you are at least 18 years old and have advanced or unresectable liver cancer confirmed by a doctor. The study plans to enroll 16 participants.

Study design
This is a single-site Phase 1 study with a planned enrollment of 16 participants. It is an interventional study, meaning participants will receive specific treatments.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Adverse events will be measured at 6 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06710223

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

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
University of California, San Diego
~16 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:SD-101CryotherapyTremelimumabDurvalumab

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Events
Measured over 6 months

Conditions

Hepatocellular Carcinoma

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Hepatocellular Carcinoma

NCT06710223

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of California, San Diego

    San Diego, Californiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Adam Burgoyne, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Diego

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Willing and able to provide written informed consent prior to performance of any study- specific procedures.
Age ≥ 18 years.
Locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants:
HCC with a component that measures at least 3 cm and that is located 1 cm or greater away from sensitive structures, including large blood vessels, large bile ducts, pericardium, diaphragm, gallbladder, stomach, and bowel.
Is not a candidate for local therapies alone, including liver transplantation, tumor ablation, transarterial embolization, radiation therapy, or resection.
No prior systemic therapy for advanced or metastatic HCC.
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
Evaluable target lesions as per Response Evaluation Criteria in Solid Tumors RECIST v1.1 or mRECIST.
Child-Pugh A or Child-Pugh B7 liver function.
Life expectancy of ≥ 12 weeks.
Adequate bone marrow function defined as:
Adequate renal function defined as creatinine clearance ≥ 50 ml/min
Adequate liver and pancreatic function defined as:
Adequate central nervous system function defined as:
Systolic blood pressure \<160 mm Hg.
Patients with partners of childbearing potential must agree to use adequate contraception during participation in the study.
Patients able to become pregnant are eligible to enter the study if they are either:

Exclusion

Brain metastases or spinal cord compression, unless treatment was completed at least 4 weeks before study entry, and stable without steroid treatment for at least 4 weeks.
Evidence of severe or uncontrolled systemic diseases \[e.g., unstable or uncompensated respiratory, cardiac (including life threatening arrhythmias)\].
Unresolved toxicity ≥ CTCAE Grade 2 from previous anti-cancer therapy except alopecia (if applicable) unless agreed that the patient can be entered after discussion with the Medical Monitor.
Presence of cardiac impairment defined as:
Participation in a trial of an investigational agent within the prior 30 days
Pregnant or breast-feeding.
High volume peritoneal or pleural effusions requiring centesis more frequently than every 14 days.
Poorly controlled or refractory (grade 3-4) hepatic encephalopathy.
History of allogeneic stem cell or solid organ transplantation.
Prior history of pneumonitis/interstitial lung disease.
Receipt of live vaccine within 30 days.
Active or prior documented autoimmune or inflammatory disorders (including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis). The following are exceptions to this criterion:
Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
Any concurrent condition that, in the investigator's opinion, makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.

What this trial measures

  • Adverse Events6 months

    The primary endpoint is the number and frequency of adverse events related to cryoablation and hepatic artery infusion of SD-101 in combination with durvalumab and tremelimumab. Adverse events (AEs) during the 6 months following Cryo+SD-101 will be recorded. The NCI CTCAE version 5.0 will be used to grade adverse events. Incidence of AEs will be summarized by event type, grade and body system. Particularly, the rates of infusion reactions, major bleeding, major infection, and grade 3 or above non-infection adverse events will be reported. The proportion of patients having each type of adverse event will be summarized along with a corresponding 90% confidence interval calculated using the exact method. The rate and 90% exact CI of subjects who experience serious adverse events will also be reported.