SIRT With Tremelimumab and Durvalumab for Resectable HCC
Eligible age
18+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
The goal of this research study is to evaluate the safety and tolerability of tremelimumab and durvalumab with or without Selective Internal Yttrium-90 Radioembolization (SIRT) in participants with resectable hepatocellular carcinoma (HCC) who will undergo liver surgery. The names of the interventions involved in this study are: * Durvalumab (a type of immunotherapy) * Tremelimumab (a type of immunotherapy) * Selective Internal Yttrium-90 Radioembolization (SIRT) (a type of radiation microsphere bead)
Sponsor: Jiping Wang, MD, PhD
You may qualify if…
- ✓ 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:
You may not qualify if…
- ✕ 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
Where it's recruiting
Los Angeles
Boston
Source: ClinicalTrials.gov · NCT05701488 · last updated 2025-09-02