Biomarkers to predict outcomes in liver cancer treated with tremelimumab plus durvalumab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional biomarker study enrolls adults with histologically confirmed, locally advanced, metastatic, or unresectable hepatocellular carcinoma who are starting tremelimumab plus durvalumab (STRIDE) in routine care. Participants provide blood samples at scheduled timepoints so researchers can measure immune and molecular markers and link them to radiologic response and clinical outcomes using RECIST v1.1. Patients with prior exposure to PD-1, PD-L1, or CTLA-4 therapies are excluded to focus on first-line treatment effects. The multi-center effort is led by CHU de Besançon in collaboration with AstraZeneca and collects samples at French hospital sites.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Signed informed consent
2. Histologically confirmed hepatocellular carcinoma
3. Locally advanced, metastatic, or unresectable disease
4. Patient who had not previously received systemic anti-cancer treatment and are eligible to STRIDE therapy according to investigator decision in routine care and who have no contraindications to STRIDE treatment according to approved product label.
5. Measurable disease defined according to RECIST v1.1 guidelines (Note: Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation.)
6. Age ≥ 18 years
7. Patient affiliated to or beneficiary of French social security system
8. Ability to comply with the study protocol, in the Investigator's judgment.

Exclusion Criteria:

1. Patients previously exposed to anti-tumor immunotherapy as anti-PD-1, anti-PD-L1, or anti-CTLA4 agent or any immune therapy.
2. Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study
3. Patient under guardianship, curatorship or under the protection of justice

Where it's running

• CHU de Besançon
  Besançon, France Recruiting
• CH de Chalon sur Saône
  Chalon-sur-Saône, France Recruiting
• CHU Grenoble
  Grenoble, France Recruiting
• CH de Mulhouse
  Mulhouse, France Recruiting
• Hôpital Beaujon - APHP
  Paris, France Recruiting
• Hôpital Henri Mondor - APHP
  Paris, France Recruiting

Study contacts

• Study coordinator: Angélique VIENOT, Dr
• Email: a3vienot@chu-besancon.fr
• Phone: +33 3 81 66 81 66

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• STRIDE combination in advanced liver cancer: a first-line look at tremelimumab plus durvalumab

  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.

  Recruiting at 17 sites AstraZeneca · Ancona and 23 other locations · NCT07607769

• 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

• 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.