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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Durvalumab
DrugIntravenous infusion
Tremelimumab
DrugIntravenous infusion
SIRT
DeviceSIR (Selective Internal Radiation) Sphere resin microspheres, radioactive particles delivered via injection into an artery.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Durvalumab + Tremelimumab (Arm A)Experimental treatment 2 interventions
Group B: Durvalumab + Tremelimumab + SIRT (Arm B)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Number of Participants with Adverse Events
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.
Time frame
up to 18 monthsSecondary outcomes
1
Best Radiologic Response
Defined as best radiologic response on treatment and evaluated per RECIST 1.1 criteria.
Time frame
up to 15 months2
Best Pathological Response
Defined as the best pathological response based on evaluation of the surgical sample defined per protocol for gross and microscopic evaluation.
Time frame
up to 65 days3
Median Overall Survival (OS)
Calculated via the Kaplan-Meier method and defined as the time from study entry to death or censored at date last known alive.
Time frame
up to 3 years4
Median Progression-Free Survival (PFS)
Calculated via the Kaplan-Meier method and defined as the duration between randomization and documented disease progression or death, or is censored at time of last disease assessment.
Time frame
up to 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jiping Wang, MD, PhD
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
AstraZeneca
Collaborator
Sirtex Medical
Collaborator
Source ClinicalTrials.gov