Evaluation of the Contribution of Glypican-3 as a Pronostic Factor in Patients With Advanced Hepatocellular Carcinoma Treated by Immunotherapy

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Service hépato-gastroentérologie, Hôpital la Pitié-Salpêtrière
RECRUITING
Paris
Contact Information
Primary
Manon ALLAIRE, Dr
manon.allaire@aphp.fr
0142161034
Backup
Christine BROCHET, Dr
christine.brochet@aphp.fr
0142162061
Time Frame
Start Date: 2023-09-08
Estimated Completion Date: 2029-09-08
Participants
Target number of participants: 240
Treatments
Patient with hepatocellular carcinoma treated with Atezolizumab / Bevacizumab
Patients with an indication for treatment with Atezolizumab / Bevacizumab for the management of an advanced disciplinary hepatocellular carcinoma in a multidisciplinary consultation meeting.
Patient with hepatocellular carcinoma treated with Durvalumab/Trémélimumab
Patients with an indication for treatment with Durvalumab/Trémélimumab for the management of an advanced disciplinary hepatocellular carcinoma in a multidisciplinary consultation meeting.
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov