Predicting response to immunotherapy in liver cancer patients
Immunophenotype of Peripheral Blood Mononuclear Cells to Early Predict Response to Immunotherapy in Hepatocellular Carcinoma
IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06777628
This study is testing a new blood test to see if it can help predict how well liver cancer patients will respond to immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna (other) |
| Locations | 1 site (Bologna, Laura Gramantieri) |
| Trial ID | NCT06777628 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of a cytofluorimetric assay in predicting how patients with hepatocellular carcinoma (HCC) will respond to immunotherapy. It focuses on analyzing specific biomarkers in peripheral blood mononuclear cells (PBMC) to identify responders and non-responders early in the treatment process. The study will also investigate transcriptomic signatures to enhance the predictive accuracy of the assay. By comparing these biomarkers and signatures, the study seeks to improve treatment outcomes for HCC patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with hepatocellular carcinoma and are receiving treatment at the participating center.
Not a fit: Patients with immune-related concomitant diseases or HIV infection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enable earlier and more accurate predictions of treatment responses in liver cancer patients, leading to better personalized treatment strategies.
How similar studies have performed: While the approach of using immunophenotyping to predict treatment response is gaining traction, this specific methodology and its application in HCC is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age ≥ 18 years * diagnosis of HCC * execution of laboratory tests and subsequent treatments and follow-up at our center. * obtained written informed consent to the study participation Exclusion Criteria: * immune-related concomitant diseases * HIV infection
Where this trial is running
Bologna, Laura Gramantieri
- IRCCS-Azienda Ospedaliero-Universitaria di Bologna — Bologna, Laura Gramantieri, Italy (RECRUITING)
Study contacts
- Principal investigator: Laura Gramantieri — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Laura Gramantieri, MD
- Email: laura.gramantieri@aosp.bo.it
- Phone: 0512142579
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.
Conditions: Liver Cancer, Adult, immunophenotype, HCC patients, immunotherapy