STRIDE combination in advanced liver cancer: a first-line look at tremelimumab plus durvalumab
Official title: MONTEROSA Italian Multicenter Observational Study to Evaluate Time to Clinical Hepatic Decompensation, Quality of Life, Effectiveness, and Safety of Tremelimumab Plus Durvalumab in Patients With Advanced or Unresectable Hepatocellular Carcinoma Who Have Received no Prior Systemic Treatment. (Real World Observational Study of STRIDE Regimen for Advanced HCC)
Run by AstraZeneca · NCT07607769 · Data updated 2026-11-12
This study tests tremelimumab plus durvalumab as a first-line treatment in adults with advanced or unresectable hepatocellular carcinoma to see how it affects liver health, quality of life, effectiveness, and safety.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | immunotherapy, tremelimumab, durvalumab |
| Locations | 24 sites (Ancona and 23 other locations) |
| Status | Recruiting |
| Started | April 16, 2026 |
| Main results expected | October 31, 2028 |
| Study ends | October 31, 2028 |
| Registry record updated | September 29, 2026 |
| Trial ID | NCT07607769 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 and older with histologically or radiologically confirmed advanced or unresectable HCC (BCLC B/C), Child-Pugh A, ECOG 0–1, and no prior systemic therapy.
✕Probably not a fit
Patients with main trunk portal vein thrombosis, autoimmune disease needing immunosuppressives, active GI bleeding, prior immunotherapy, or other exclusion criteria may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Italian multicenter observational study follows adults with advanced or unresectable hepatocellular carcinoma who have not received prior systemic therapy. Participants receive the STRIDE regimen and are followed to measure time to hepatic decompensation, quality of life, treatment effectiveness, and safety outcomes. The study does not randomize treatment and aims to describe real-world use of this first-line immunotherapy combination. Key eligibility includes Child-Pugh A status, ECOG 0–1, and BCLC B or C disease. Sites are located in Ancona and Bergamo, with AstraZeneca as lead sponsor.
Why it matters
Potential benefit: If successful, patients may experience delayed liver decompensation and improved quality of life with STRIDE in first-line therapy for advanced HCC.
How similar studies have gone: Previous immunotherapy combinations in HCC have shown activity in some settings, but this specific first-line STRIDE observational use is exploratory and builds on emerging data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * \- Signed informed consent. * Age ≥ 18 years. * Histologically or radiologically confirmed diagnosis of advanced or unresectable HCC. * BCLC B or C HCC. * Child-Pugh A (score 5 or 6). * Eastern Cooperative Oncology Group (ECOG) Performance Status score 0 or 1. * Planned first-line treatment of advanced/uHCC with STRIDE. Exclusion Criteria: * \- Any previous line of systemic therapy for HCC. * Any prior or concomitant immunotherapy. * Prior allogeneic organ or bone marrow transplant. * Documented active or previous GI bleeding within the previous 12 months. * Main trunk portal vein thrombosis. * Autoimmune disease requiring treatment with immunosuppressive medication. * Known hypersensitivity to the active substance or to any of the STRIDE excipients. * Pregnancy or breastfeeding
Where it's running
-
Research Site
Ancona, Italy Recruiting -
Research Site
Bergamo, Italy Recruiting -
Research site
Foggia, Italy Recruiting -
Research Site
Foggia, Italy Recruiting -
Research Site
Meldola, Italy Recruiting -
Research Site
Milan, Italy Recruiting
Show 18 more locations
-
Research Site
Modena, Italy Recruiting -
Research site
Naples, Italy Recruiting -
Research Site
Naples, Italy Recruiting -
Research Site
Padova, Italy Recruiting -
Research Site
Palermo, Italy Recruiting -
Research Site
Pisa, Italy Recruiting -
Research Site
Pozzuoli, Italy Recruiting -
Research Site
Roma, Italy Recruiting -
Research Site
Rozzano, Italy Recruiting -
Research Site
Torino, Italy Recruiting -
Research Site
Verona, Italy Recruiting -
Research site
Ancona, Italy Active not recruiting -
Research site
Milan, Italy Active not recruiting -
Research site
Modena, Italy Active not recruiting -
Research site
Pozzuoli, Italy Active not recruiting -
Research site
Rozzano, Italy Active not recruiting -
Research site
Torino, Italy Active not recruiting -
Research site
Verona, Italy Active not recruiting
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: +1877240
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Durvalumab plus tremelimumab with or without liver-directed GEMOX chemotherapy for hepatocellular carcinoma
This trial tests whether adding hepatic arterial infusion chemotherapy (GEMOX) to the immunotherapy combination durvalumab plus tremelimumab helps people with hepatocellular carcinoma who have a high tumor burden in the liver.
-
Durvalumab + Tremelimumab with or without Lenvatinib for unresectable liver cancer
This trial tests whether adding lenvatinib to the STRIDE regimen (durvalumab plus tremelimumab) helps people with unresectable hepatocellular carcinoma who have not received prior systemic therapy.
-
Biomarkers to predict outcomes in liver cancer treated with tremelimumab plus durvalumab
This study will test whether blood biomarkers can predict how adults with unresectable or metastatic hepatocellular carcinoma respond to tremelimumab plus durvalumab (STRIDE regimen).
-
Combining Zanzalintinib with Immunotherapy for Liver Cancer
This study is testing a new combination of a cancer drug and immunotherapy to see if it can help people with advanced liver cancer feel better and fight their disease.
-
Treatment for advanced liver cancer with specific cirrhosis
This study is testing a new combination treatment for advanced liver cancer in patients with specific cirrhosis to see if it can help them better than current options, especially focusing on those from underserved communities.
-
Triple treatment for advanced liver cancer patients
This study is testing two different ways to treat advanced liver cancer to see which one works better for patients who can't have surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.