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

Condition(s) studied

Investigational drug(s) / intervention(s)

Quantitative assay of GlypicanPC-3: Quantitative assay of GlypicanPC-3 in human serum is performed by direct sandwich immunoassay ( CanAg Glypican3 EIA - Fujirebio ) on microplate using two mouse monoclonal antibodies against two epitopes of the Glypican-3 core protein

Study summary

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.

Eligibility

Primary outcome measure(s)

• evaluate concentration of circulating GPC-3 — at inclusion, at 3 weeks and at 3 months of the first infusion of Atezolizumab/Bevacizumab
  Evaluation of the change in GPC-3 concentration before, at 3 weeks (second infusion) and at 3 months from the first infusion of Atezolizumab/Bevacizumab .

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France

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