Clinical trial Recruiting at 17 sites Observational Ages 18 to 100

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.

More Hepatocellular Carcinoma trials

Quick facts

Study typeObservational
Ages18 Years to 100 Years
SexAll
Enrollment200 (estimated)
SponsorAstraZeneca
Industry-sponsored
Drugs / interventionsimmunotherapy, tremelimumab, durvalumab
Locations24 sites (Ancona and 23 other locations)
StatusRecruiting
StartedApril 16, 2026
Main results expectedOctober 31, 2028
Study endsOctober 31, 2028
Registry record updatedSeptember 29, 2026
Trial IDNCT07607769 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

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.

    Recruiting at 5 sites Phase 2/3 Unicancer · Bordeaux and 10 other locations · NCT06904170

  • 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.

    Recruiting at 13 sites Phase 2 Canadian Cancer Trials Group · Calgary, Alberta and 12 other locations · NCT06880523

  • 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).

    Recruiting at 10 sites Centre Hospitalier Universitaire de Besancon · Besançon and 9 other locations · NCT06796114

  • 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.

    Recruiting Phase 2 University of Pittsburgh · Pittsburgh, Pennsylvania and 2 other locations · NCT06698250

  • 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.

    Recruiting Phase 2 The University of Texas Health Science Center at San Antonio · San Antonio, Texas · NCT06526104

  • 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.

    Recruiting at 3 sites Phase 2 Ludwig-Maximilians - University of Munich · Munich and 2 other locations · NCT05844046

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.