Identification of Innovative Biomarkers to Predict Outcomes in Hepatocellular Carcinoma Treated With Tremelimumab and Durvalumab
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
Several cancer immunotherapies that target the PD-L1/PD-1 pathway (i.e., checkpoint inhibitors) show promising clinical activity in patients with HCC. In particular, atezolizumab selectively targets PD-L1 to prevent interaction with receptors PD-1 and B7-1, thus reversing T-cell suppression. Moreover, atezolizumab in combination with bevacizumab, a monoclonal antibody that targets VEGF and inhibits angiogenesis, is associated with an objective response rate of 27.3% (Cheng et al. 2021; Finn et al. 2020). This tumor response has led to FDA (Food and Drug Administration) and EMA (European Medicines Agency) approvals, in first-line treatment in unresectable HCC. Combinations studies evaluating anti-CTLA4 and anti-PD1/PDL1 antibodies displayed greater benefits (Abou-Alfa et al. 2022). In the Phase 3 HIMALAYA study (NCT03298451) in uHCC, a single priming dose of tremelimumab (anti-CTLA-4) plus durvalumab (anti-PD-L1) in the STRIDE (Single Tremelimumab Regular Interval Durvalumab) regimen significantly improved OS versus sorafenib; durvalumab monotherapy was noninferior to sorafenib for OS. In the HIMALAYA study, STRIDE regimen induced long term survival (defined as the absence of progression above 36 months following inclusion) in 103 out of the 393 patients exposed to this strategy (26%). The identification of biomarkers allowing the prediction of immunotherapy efficacy in HCC is still an unmet medical need.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzona histologicznie diagnoza raka wątroby
- •Zaawansowany, nieoperacyjny lub rozsiany nowotwór
- •Pacjent bez poprzedniego leczenia przeciwnowotworowego i kwalifikujący się do schematu STRIDE
- •Mierzalne zmiany nowotworowe widoczne na badaniach
- •Wiek co najmniej 18 lat
- •Ubezpieczenie w francuskim systemie zabezpieczenia społecznego
- •Zdolność do przestrzegania protokołu badania
- •Podpisana świadoma zgoda na udział w badaniu
✗ Disqualifies
- •Poprzednie leczenie immunoterapią (przeciw PD-1, PD-L1 lub CTLA-4)
- •Schorzenia psychiczne lub medyczne, które mogłyby stanowić zagrożenie w badaniu
- •Pobycie pod opieką sądową lub sprawowaniem kurateli
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 23, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (10)
CHU de Besançon
Besançon, France
CH de Chalon sur Saône
Chalon-sur-Saône, France
CHU Grenoble
Grenoble, France
CH de Mulhouse
Mulhouse, France
Hôpital Beaujon - APHP
Paris, France
Hôpital Henri Mondor - APHP
Paris, France
Hôpital La Pitié Salpêtrière - APHP
Paris, France
CHU Poitiers
Poitiers, France
CHU de Reims
Reims, France
Centre Paul Strauss
Strasbourg, France
Trial contact
Angélique VIENOT, Dr
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/24/2026.
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