Glypican-3 as a Prognostic Factor in Patients With Hepatocellular Carcinoma Treated by Immunotherapy

Recruiting now

Conditions studied: Hepatocellular Carcinoma

In brief

Recently, the positive results of the Imbrave 150 study (randomized study comparing Atezolizumab+Bevacizumab versus Sorafenib) prompted investigators to redefine their management strategy for advanced HCC by proposing the combination Atezolizumab+ Bevacizumab as first-line treatment in these patients. Identifying new predictive biomarkers of response is essential to optimize the identification of patients who will benefit from immunotherapy. Glypican-3 (GPC-3) is a cell surface glycoprotein that belongs to the family of heparan sulfate chain proteoglycan that is directly implicated in several cancers and more particularly in HCC. GPC-3 overexpression in serum predicts a poor prognosis for patients with HCC and is associated with early tumor recurrence. Through this study, the investigators want to determine whether the concentration of circulating GPC-3 alone, or in combination with other biomarkers used in current practice (PIVKA, AFP) could predict the response to treatment with Atezolizumab/Bevacizumab and OS.

Key facts

Study ID

NCT05263830

Run by

Assistance Publique - Hôpitaux de Paris

People needed

240

Starts

2023-09-08

Expected to finish

2029-09-08

Last updated by the study team

2025-12-16

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years ≤ age < 90 years
• Diagnosed with HCC developed on a cirrhotic liver or on chronic liver disease that has not reached the stage of cirrhosis regardless of the etiology diagnosed according to the diagnostic criteria for TNCD updated in June 2021 (1)
• Having an indication for systemic therapy with Atezolizumab+Bevacizumab validated in multidisciplinary meeting according to the current recommendations of cancer societies.
• Understanding the French language.
• Having been informed and accepted to participate to the study.

You may not qualify if…

• HIV or known immune deficiency or immunosuppressive treatment
• Autoimmune diseases or other immunotherapies
• History of portosystemic shunt or liver transplantation
• Sepsis, vasoconstrictor drugs.
• Pregnant or breastfeeding women
• Protected populations: under guardianship or curators

Where it is running

• Service hépato-gastroentérologie, Hôpital la Pitié-Salpêtrière — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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