Biomarkers to predict outcomes in liver cancer treated with tremelimumab plus durvalumab
Identification of Innovative Biomarkers to Predict Outcomes in Hepatocellular Carcinoma Treated With Tremelimumab and 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).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Besancon Academic / other |
| Drugs / interventions | immunotherapy, radiation, atezolizumab, bevacizumab, tremelimumab, durvalumab |
| Locations | 10 sites (Besançon and 9 other locations) |
| Trial ID | NCT06796114 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18) in France with histologically confirmed unresectable, locally advanced, or metastatic hepatocellular carcinoma who have not received prior systemic immunotherapy and are eligible for STRIDE treatment.
Not a fit: Patients previously treated with PD-1, PD-L1, or CTLA-4 immune therapies, those with resectable disease, or people not eligible for STRIDE or not covered by the French social security system are unlikely to benefit from joining.
Why it matters
Potential benefit: If successful, the biomarkers could help doctors predict who is likely to benefit from the STRIDE tremelimumab‑durvalumab regimen and personalize treatment choices.
How similar studies have performed: Combination tremelimumab plus durvalumab showed clinical benefit in the phase 3 HIMALAYA trial, but predictive biomarkers for response remain exploratory and are not yet clinically validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Besançon and 9 other locations
- 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 (Not_yet_recruiting)
- Hôpital La Pitié Salpêtrière - APHP — Paris, France (Recruiting)
- CHU Poitiers — Poitiers, France (Not_yet_recruiting)
- CHU de Reims — Reims, France (Not_yet_recruiting)
- Icans — Strasbourg, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Angélique VIENOT, Dr
- Email: a3vienot@chu-besancon.fr
- Phone: +33 3 81 66 81 66
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.