SIRT with Tremelimumab and Durvalumab for Resectable Liver Cancer
This study is testing the safety of combining two immunotherapy drugs, Durvalumab and Tremelimumab, with or without Selective Internal Radiation Therapy (SIRT) in people with liver cancer (hepatocellular carcinoma or HCC) that can be removed by surgery. Immunotherapy helps your body's immune system fight cancer. SIRT uses tiny radioactive particles injected into an artery to treat the tumor. The main goal is to see how safe these treatments are when given before liver surgery. You may be able to join if you are 18 or older and have confirmed HCC. About 20 people are expected to participate in this study, which is currently unclear if it's recruiting.
- Study design
- This is a Phase 1, open-label study where about 20 participants will be randomly assigned to receive Durvalumab + Tremelimumab or Durvalumab + Tremelimumab + SIRT.
- What's involved
- You would undergo screening, receive study treatment, have radiology scans, blood tests, electrocardiograms, and follow-up visits. Participation is expected to last about 18 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for a maximum of 3 years after treatment, with safety measured for up to 18 months.
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NCT05701488
SIRT With Tremelimumab and Durvalumab for Resectable HCC
Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatmentJiping Wang, MD, PhDInvestigator-initiated
~20 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:DurvalumabTremelimumabSIRT
At a glance
Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Adverse Events
Measured over up to 18 months
Conditions
NCT05701488
Where you'd take part
This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Beth Israel Deaconess Medical Center
Boston, Massachusettsno site contact published
Cedars-Sinai Medical Center
Los Angeles, Californiano site contact published
Dana-Farber Cancer Institute
Boston, Massachusettsno 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
- Jiping Wang, MD, PhD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Eligibility criteria
Inclusion
Histologically confirmed HCC (documentation of original biopsy for diagnosis is acceptable if tumor tissue is unavailable) or clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic subjects (presence of arterial hypervascularity with venous washout). For subjects without cirrhosis, histological confirmation is mandatory.
Participants must have resectable disease. Those patients must have preserved liver function (Child A) and with either AJCC stage IA, IB, II, and IIIA or BCLC stage 0 or stage A disease. The determination of resectability will ultimately lie in the clinical judgment of the treating investigator and surgical oncologist involved in the care of the patient.
Participants must be treatment naïve for HCC.
Age ≥18 years. Because no dosing or adverse event data are currently available on the use of tremelimumab, durvalumab, and SIRT in participants \<18 years of age, children are excluded from this study.
Measurable disease per RECIST 1.1 criteria.
ECOG performance status ≤ 1 (see Appendix A).
Body weight \>30 kg.
Participants must have adequate organ and marrow function as defined below:
Hemoglobin ≥ 9.0 g/dL
Absolute Neutrophil Count (ANC) ≥ 1,000 /mcL
Platelets ≥ 80,000 /mcL
Total Bilirubin ≤ 2.0 mg/dL
AST (SGOT) and ALT (SGPT) ≤ 2.5 × institutional upper limit of normal (ULN)
Measured Creatinine Clearance \> 40 mL/min by 24-hour urine collection, or
Calculated Creatinine Clearance (CL) \> 40 mL/min by the Cockcroft-Gault Formula (Cockcroft Gault 1976):
Males: Creatinine CL (mL/min) = (weight (kg) × (140 - Age)) / (72 × serum creatinine (mg/dL))
Females: Creatinine CL (mL/min) = (weight (kg) × (140 - Age) / (72 × serum creatinine (mg/dL))) × 0.85
Women of childbearing potential (WOCBP, refer to Section 5.4) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) obtained during the trial screening period.
Men and WOCBP must agree to follow the protocol instructions for acceptable method(s) of contraception for the duration of trial treatment and for a total of 5 months post-treatment completion. Refer to Section 5.4.
Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen as assessed by the treating investigator are eligible for this trial.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion
Participants who have received any prior treatment for HCC.
Patients who have had a major surgical procedure, open biopsy, or significant traumatic injury with poorly healed wound within 6 weeks prior to first dose of study drug.
History of allogenic organ transplantation.
Participants who are receiving any other investigational agents.
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\]). The following are exceptions to this criterion:
Patients with vitiligo or alopecia
Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
Any chronic skin condition that does not require systemic therapy
Patients with celiac disease controlled by diet alone
Patients without active disease in the last 5 years may be included but only after consultation with the sponsor-investigator
History of allergic reactions attributed to compounds of similar chemical or biologic composition to durvalumab or tremelimumab.
Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection (including tuberculosis), uncontrolled hypertension (defined as blood pressure of \> 140/90 mmHg during the screening period despite medical management), interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent.
Patients who have a primary brain tumor (excluding meningiomas and other benign lesions), any brain metastases, leptomeningeal disease, seizure disorders not controlled with standard medical therapy, or history of a stroke within the year prior to the first dose of study drug.
History of active primary immunodeficiency.
Known active infection of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
Patients positive for HIV are allowed on study, but HIV-positive patients must have:
A stable regimen of highly active anti-retroviral therapy (HAART)
No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
A CD4 count above 250 cells/mcL and an undetectable HIV viral load or standard PCR-based tests
Known active hepatitis B infection (known positive HBV surface antigen (HBsAg) result). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible.
Known active hepatitis C infection. Participants positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
Current or prior use of immunosuppressive medication within 14 days before the first dose of study agent. The following are exceptions to this criterion:
Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection)
Systemic corticosteroids at physiologic doses that do not exceed 10 mg/day of prednisone or its equivalent
Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
Receipt of live attenuated vaccine within 30 days prior to the first dose of study drug. Note: Patients, if enrolled, should not receive live vaccine whilst receiving study drug and for at least 30 days after the last dose of study agent.
History of serious systemic disease, including myocardial infarction or unstable angina within the 12 months prior to the first dose of study drug, history of hypertensive crisis or hypertensive encephalopathy, New York Heart Association (NYHA) grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), significant vascular disease or symptomatic peripheral vascular disease.
Participants who have a known clinical history of coagulopathy, bleeding diathesis, or thrombosis within the 12 months prior to the first dose of study drug.
Participants who have a serious, non-healing wound, ulcer, bone fracture or with history of pneumonitis or interstitial lung disease.
Participants who are pregnant or breastfeeding. A negative serum or urine pregnancy test obtained during the screening period is required for trial enrollment.
Participants requiring total parenteral nutrition with lipids.
What this trial measures
- Number of Participants with Adverse Eventsup to 18 months
Defined as All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv5 as reported on case report forms were counted. Rate is the proportion of treated participants experiencing at least one treatment-related grade 3-5 AE of any type during the time of observation.