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NCT Number: NCT06796114

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

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Besançon, Besançon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent
  • Histologically confirmed hepatocellular carcinoma
  • Locally advanced, metastatic, or unresectable disease
  • 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.
  • 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.)
  • Age ≥ 18 years
  • Patient affiliated to or beneficiary of French social security system
  • Ability to comply with the study protocol, in the Investigator's judgment.

Exclusion criteria

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

Treatment and study plan

blood sample

Other

A total of 48 ml of blood will be collected at baseline (before STRIDE initiation):

  • 6 EDTA 6 ml tubes for PBMC collection
  • 2 EDTA 6 ml tube for plasma collection

Primary outcomes

  1. real-word overall survival

    Time frame: through study completion, up to a maximum of 24 months after the inclusion of the last patient

    defined as the delay from the date of treatment initiation to death from any cause

Secondary outcomes

  1. real-word progression-free-survival

    Time frame: through study completion, up to a maximum of 24 months after the inclusion of the last patient

    defined as the delay from the date of treatment initiation to the disease progression or death from any cause whichever occurs first, evaluated by RECIST criteria v1.1 and mRECIST.

  2. Objective Response Rate (ORR)

    Time frame: through study completion, up to a maximum of 24 months after the inclusion of the last patient

    defined as the addition of complete response and partial response rates, evaluated by RECIST citeria v1.1 and mRECIST

  3. Disease control rate (DCR)

    Time frame: through study completion, up to a maximum of 24 months after the inclusion of the last patient

    defined as the addition of complete response, partial response, and stable disease rates evaluated by RECIST criteria v1.1 and mRECIST.

Study contacts

Contact information is provided by the study sponsor or research team.

Angélique VIENOT, Dr

CONTACT

[email protected]

+33 3 81 66 81 66

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Collaborators

  • AstraZeneca

Registry information

Acronym: PREDICT-HCC

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Jan 28, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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