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New treatment option for Hepato Cellular Carcinoma
Official title IIT2025-03-YANG-LIFT-HCC
ClinicalTrials.gov ID: NCT07489976
What this study is testing
What is STRIDE Regimen (Tremelimumab 300 mg AND Durvalumab 1500 mg) combined with LRT (TACE, TARE, or RFA)?
STRIDE Regimen (Tremelimumab 300 mg AND Durvalumab 1500 mg) combined with LRT (TACE, TARE, or RFA) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepato cellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Histologically confirmed HCC via liver biopsy obtained within 3 months prior to initiation of study treatment as part of SOC. If no historical biopsy...
- ECOG performance status ≤ 2 within 7 days prior to initiation of study treatment. Child-Pugh A or B7 (5 to 7 points) at screening and within 7 days...
- HCC with Measurable disease by mRECIST (see Appendix 11.2) (at least one ≥10mm target lesion) that is not suitable for resection per standard...
You likely can't join if
- 1- Known fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC. 2- Extrahepatic spread with organ...
- Participants who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication...
- Participants who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or...
See the full eligibility criteria
- 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...
- ECOG performance status ≤ 2 within 7 days prior to initiation of study treatment. Child-Pugh A or B7 (5 to 7 points) at screening and within 7 days prior to study treatment. D1 ECOG/CTP may not repeat if screening...
- HCC with Measurable disease by mRECIST (see Appendix 11.2) (at least one ≥10mm target lesion) that is not suitable for resection per standard clinical practice and beyond UCSF criteria (see section 11.5) confirmed with...
- For people of childbearing potential (SOCBP), negative serum or urine pregnancy test and agreement to use adequate contraception or abstinence from the time of screening until 3 months following the last dose of...
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- 1- Known fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC. 2- Extrahepatic spread with organ involvement other than liver. 3- Portal vein tumor thrombus (VP3-4) or any...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.