Evaluating Glypican-3 as a Prognostic Factor in Hepatocellular Carcinoma Patients Treated with Immunotherapy
Evaluation of the Contribution of Glypican-3 as a Pronostic Factor in Patients With Advanced Hepatocellular Carcinoma Treated by Immunotherapy
This study is testing if a protein called Glypican-3 can help predict how well patients with liver cancer will respond to a specific immunotherapy treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | Atezolizumab, Bevacizumab, immunotherapy |
| Locations | 1 site (Paris) |
| Trial ID | NCT05263830 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the role of Glypican-3 (GPC-3) as a prognostic biomarker in patients with hepatocellular carcinoma (HCC) receiving treatment with Atezolizumab and Bevacizumab. The study will measure the concentration of circulating GPC-3 and evaluate its predictive value for treatment response, alongside other biomarkers like PIVKA and AFP. By identifying patients who are more likely to benefit from immunotherapy, the study seeks to optimize treatment strategies for advanced HCC. The findings could lead to improved patient outcomes by tailoring therapies based on biomarker profiles.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 90 diagnosed with hepatocellular carcinoma on a cirrhotic liver or chronic liver disease, who are eligible for systemic therapy with Atezolizumab and Bevacizumab.
Not a fit: Patients with HIV, autoimmune diseases, or those undergoing immunosuppressive treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict which patients will respond best to immunotherapy, potentially improving survival rates and treatment outcomes.
How similar studies have performed: Other studies have shown promising results in using biomarkers for predicting treatment responses in HCC, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 this trial is running
Paris
- Service hépato-gastroentérologie, Hôpital la Pitié-Salpêtrière — Paris, France (Recruiting)
Study contacts
- Principal investigator: Manon ALLAIRE, Dr — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Manon ALLAIRE, Dr
- Email: manon.allaire@aphp.fr
- Phone: 0142161034
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.