SIRT With Tremelimumab and Durvalumab for Resectable HCC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiping Wang, MD, PhD
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Durvalumab
- Tremelimumab
- SIRT
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Jiping Wang, MD, PhD
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
AstraZeneca
Collaborator
Sirtex Medical
Collaborator
Source ClinicalTrials.gov