RecruitingNot applicableEN originalLiver cancerMetastatic / advanced

Identification of Innovative Biomarkers to Predict Outcomes in Hepatocellular Carcinoma Treated With Tremelimumab and Durvalumab

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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

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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