Hepato Cellular CarcinomaPhase 2NCT07489976
IIT2025-03-YANG-LIFT-HCC
A Phase 2 study testing STRIDE Regimen (Tremelimumab 300 mg AND Durvalumab 1500 mg) combined with LRT (TACE, TARE, or RFA) in people with Hepato Cellular Carcinoma, run by Ju Dong Yang at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepato Cellular Carcinoma
- What is being tested?
- STRIDE Regimen (Tremelimumab 300 mg AND Durvalumab 1500 mg) combined with LRT (TACE, TARE, or RFA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 31 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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 ECOG/CTP collected within 7 days prior to D1.
- 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 most recent imaging obtained within 3 months prior to screening.
- For subjects 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 Durvalumab.
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Who cannot join
- 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 viable hepatic vein tumor thrombus at screening.
- 4- History of immune therapy exposure (and-PD-1, and PDL-1, and anti-CTLA-4) treatment.
- 5- Is pregnant or breastfeeding or expecting to conceive or impregnate someone during the study period.
- 6- Active or history of autoimmune diseases, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis.
- 7- Patient lacks interest or inadequate psychosocial support for organ transplantation.
Show all 20Show fewer
- 8- Patients who have a known concurrent malignancy that is progressing or requires active treatment, who have not completely recovered from prior treatment, or who have a significant malignancy history that, in the opinion of the investigator, should preclude participation.
- 9- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
- 10- Active tuberculosis (TB), as documented by a positive purified protein derivative (PPD) skin test or TB blood test and confirmed by a positive chest X-ray within 3 months prior to initiation of study treatment.
- 11- Active co-infection with HBV and HCV. Participants with a history of HCV infection but who are negative for HCV RNA by PCR will be considered non-infected with HCV.
- 12- Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion of the investigator, could impact participant safety.
- 13- Treatment with investigational therapy within 28 days prior to initiation of study treatment.
- 14- Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and IL-2) within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment.
- 15- Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:
- 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.
- 16- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during study treatment, within 5 months after the final dose of ICI.
- 17- Radiotherapy within 28 days, or abdominal/pelvic radiotherapy within 60 days, prior to initiation of study treatment.
- 18- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of study treatment; or abdominal surgery, abdominal interventions, or significant abdominal traumatic injury within 60 days prior to initiation of study treatment; anticipation of need for major surgical procedure during the course of the study; or non-recovery from side effects of any such procedure.
- 19- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of the study drugs, may affect the interpretation of the results, or may render the participant at high risk from treatment complications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars Sinai
Los Angeles, California, 90048
Manaf Alsudaney, MD, 310-967-7454, manaf.alsudaney@csh.org
Manaf Alsudaney, MD, 3109677454, manaf.alsudaney@cshs.org
About this study
Official title: Leveraging Immunotherapy For Tumor Downstaging to Milan Criteria in Patients With Hepatocellular Carcinoma
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.
Read the detailed description
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.
What are the study treatments? The patients will receive immunotherapy medicines through a vein (IV). The first treatment is a combination of tremelimumab and durvalumab, called STRIDE. After that, the patients may continue durvalumab about once every 4 weeks up to total of 12 cycles on study. The patients will also have a liver-directed tumor treatment (LRT), which is a procedure to treat the tumor inside the liver. Depending on what is best for the patients, this may include Yttrium-90 (Y90) (radiation delivered inside the liver), TACE (chemotherapy delivered directly to the liver tumor through a small tube placed in a blood vessel), or RFA (heat used to destroy the tumor). These procedures are done by a specialist using imaging guidance, and the patients may receive medicine to help the patients relax or sleep. The patients will be monitored during and after the procedure.
The patients are being asked to take part in this research study because the patients have intermediate or advanced hepatocellular carcinoma (HCC).
The U.S. Food and Drug Administration (FDA) has approved those drugs as they are being used in this study.
Another purpose of this study is for researchers to learn if a biomarker test is helpful in determining long-term effects of ICI. A biomarker is a biological molecule found in blood, other body fluids or tissues. Biomarkers may be a sign of a condition or disease. Biomarkers also can be used to predict patient's response to a specific treatment.
The study will include up to 41 patients total.
- Conditions
- Hepato Cellular Carcinoma
- Being tested
- STRIDE Regimen (Tremelimumab 300 mg AND Durvalumab 1500 mg) combined with LRT (TACE, TARE, or RFA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Age ≥ 18 Patients with HCC beyond UCSF criteria, ECOG performance status ≤ 2, and Child-Pugh A or B7 | Experimental | STRIDE Regimen (Tremelimumab 300 mg AND Durvalumab 1500 mg) combined with LRT (TACE, TARE, or RFA) Receives: Drug: STRIDE Regimen (Tremelimumab 300 mg AND Durvalumab 1500 mg) combined with LRT (TACE, TARE, or RFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 month
Secondary 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.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepato Cellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ju Dong Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ju Dong Yang, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489976
- Sponsor's protocol ID
- STUDY00004540
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Immunotherapy For Tumor Downstaging to Milan Criteria in Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07489976
- Acronym / sponsor ID
- STUDY00004540
- Conditions
- Hepato Cellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Ju Dong YangUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
What are the study treatments? The patients will receive immunotherapy medicines through a vein (IV). The first treatment is a combination of tremelimumab and durvalumab, called STRIDE. After that, the patients may continue durvalumab about once every 4 weeks up to total of 12 cycles on study. The patients will also have a liver-directed tumor treatment (LRT), which is a procedure to treat the tumor inside the liver. Depending on what is best for the patients, this may include Yttrium-90 (Y90) (radiation delivered inside the liver), TACE (chemotherapy delivered directly to the liver tumor through a small tube placed in a blood vessel), or RFA (heat used to destroy the tumor). These procedures are done by a specialist using imaging guidance, and the patients may receive medicine to help the patients relax or sleep. The patients will be monitored during and after the procedure.
The patients are being asked to take part in this research study because the patients have intermediate or advanced hepatocellular carcinoma (HCC).
The U.S. Food and Drug Administration (FDA) has approved those drugs as they are being used in this study.
Another purpose of this study is for researchers to learn if a biomarker test is helpful in determining long-term effects of ICI. A biomarker is a biological molecule found in blood, other body fluids or tissues. Biomarkers may be a sign of a condition or disease. Biomarkers also can be used to predict patient's response to a specific treatment.
The study will include up to 41 patients total.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Age ≥ 18 Patients with HCC beyond UCSF criteria, ECOG performance status ≤ 2, and Child-Pugh A or B7 | Experimental | Drug: 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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 ECOG/CTP collected within 7 days prior to D1.
Key exclusion criteria (20 listed)
- 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 viable hepatic vein tumor thrombus at screening.
- 4- History of immune therapy exposure (and-PD-1, and PDL-1, and anti-CTLA-4) treatment.
- 5- Is pregnant or breastfeeding or expecting to conceive or impregnate someone during the study period.
- 6- Active or history of autoimmune diseases, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STRIDE Regimen (Tremelimumab 300 mg AND Durvalumab 1500 mg) combined with LRT (TACE, TARE, or RFA)• 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. | Drug | Age ≥ 18 Patients with HCC beyond UCSF criteria, ECOG performance status ≤ 2, and Child-Pugh A or B7 |
Primary outcome
Proportion of participants downstaged from beyond UCSF criteria to within Milan criteria by radiographic assessment
Time frame: 12 month
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.
1 secondary outcome
Proportion of participants downstaged from beyond UCSF criteria to within Milan criteria by radiographic assessment
Time frame: 12 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STRIDE Regimen (Tremelimumab 300 mg AND Durvalumab 1500 mg) combined with LRT (TACE, TARE, or RFA) in people with Hepato Cellular Carcinoma, run by Ju Dong Yang at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ju Dong Yang, MD (310-423-6000, judong.yang@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants downstaged from beyond UCSF criteria to within Milan criteria by radiographic assessment (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.