IIT2025-03-YANG-LIFT-HCC
ConditionHepato Cellular Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJu Dong Yang
About this trial
The investigators are doing this study to learn if a combination of immunotherapy and a liver-directed tumor procedure can safely and effectively shrink or control liver cancer (hepatocellular carcinoma, HCC). The goal is to try to lower the stage of the cancer so that more patients may become eligible for a liver transplant. The investigators will also closely watch for side effects from the study treatments. Section 2 has more details.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 at the time of signing the Informed Consent Form.
Beyond UCSF criteria HCC with diagnosis confirmed histologically/cytologically, radiologically, or clinically per AASLD criteria, with life expectancy of at least 12 months.
Histologically confirmed HCC via liver biopsy obtained within 3 months prior to initiation of study treatment as part of SOC. If no historical biopsy is available, a biopsy must be performed at screening for confirmation. Screening liver biopsy may be conducted as part of research activities if not performed per SOC practice.
ECOG performance status ≤ 2 within 7 days prior to initiation of study treatment.
Disqualifiers
1- Known fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC.
Participants who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible.
Participants who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.
Trial design
Design model
Single group
Treatments tested in this trial
STRIDE Regimen (Tremelimumab 300 mg AND Durvalumab 1500 mg) combined with LRT (TACE, TARE, or RFA)
Drug• To assess the success rate of combining ICIs and LRT (as neoadjuvant treatment) in tumor downstaging to Milan Criteria within 12 months of baseline STRIDE treatment in patients with HCC exceeding the University of California San Francisco (UCSF) criteria.
Treatment groups
41 Participants
are divided into 1 treatment groupGroup A: Age ≥ 18 Patients with HCC beyond UCSF criteria, ECOG performance status ≤ 2, and Child-Pugh A or B7Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants downstaged from beyond UCSF criteria to within Milan criteria by radiographic assessment
The primary outcome is the proportion of enrolled participants with hepatocellular carcinoma who are successfully downstaged from disease burden exceeding UCSF criteria at baseline to within Milan criteria within 12 months after initiation of STRIDE-based therapy and locoregional treatment. Downstaging status will be determined by follow-up contrast-enhanced CT or MRI using the study's predefined imaging assessment criteria.
Time frame
12 monthSecondary outcomes
1
Proportion of participants downstaged from beyond UCSF criteria to within Milan criteria by radiographic assessment
This secondary outcome measure is the proportion of participants with hepatocellular carcinoma who are successfully downstaged from tumor burden exceeding UCSF criteria at baseline to within Milan criteria within 12 months after initiation of STRIDE therapy combined with locoregional treatment. Downstaging status will be determined by contrast-enhanced CT or MRI using the study's predefined imaging assessment criteria.
Time frame
12 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ju Dong Yang
Lead sponsor
Cedars-Sinai Medical Center
Sponsor institution
Source ClinicalTrials.gov