NCT05701488 SIRT With Tremelimumab and Durvalumab for Resectable HCC
| NCT ID | NCT05701488 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Jiping Wang, MD, PhD |
| Condition | Resectable Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-04-21 |
| Primary Completion | 2026-10-01 |
Trial Parameters
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Brief Summary
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)
Eligibility Criteria
Inclusion Criteria: * 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 s
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