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Recruiting Phase 1 NCT05701488

NCT05701488 SIRT With Tremelimumab and Durvalumab for Resectable HCC

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Clinical Trial Summary
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

Condition Resectable Hepatocellular Carcinoma
Sponsor Jiping Wang, MD, PhD
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-04-21
Completion 2026-10-01
Interventions
DurvalumabTremelimumabSIRT

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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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