Cholangiocarcinoma, Hepatocellular Carcinoma (HCC)
Conditions
Keywords
immunotherapy
Brief summary
The project aims to collect blood, tissue samples, and clinical data from patients with primary liver cancer (mainly hepatocellular carcinoma and intrahepatic cholangiocarcinoma) undergoing systemic therapy, surgical resection, or liver biopsy. Primary liver cancer is a growing global health challenge, with over one million cases expected by 2025 and a lack of effective treatments. The three-year study will systematically collect and store samples to support translational research for new therapies. Blood will be drawn at key points during systemic therapy, while tissue samples will be obtained from surgical resections or biopsies, provided they are not needed for diagnostics.
Detailed description
The project aims to collect blood and tissue samples, as well as clinical data, from patients with primary liver cancer undergoing systemic therapy, surgical resection, or liver biopsy. Primary liver cancers represent a global health challenge, with an estimated incidence exceeding one million cases by 2025. Hepatocellular carcinoma (HCC) is the most common form, accounting for approximately 90% of cases. The second most common type, intrahepatic cholangiocarcinoma (iCCA), is an epithelial tumor arising along second-order bile ducts, often in patients without known risk factors. The lack of effective therapies, along with the increasing incidence and mortality rates, drives the need to explore new therapeutic approaches. These approaches require robust translational studies, which can only be conducted through the systematic collection of biological samples from patients undergoing systemic therapy. The three-year study plans to collect, process, and store blood and tissue samples from patients with primary liver cancer undergoing systemic therapy, surgical resection, or liver biopsy. For each patient undergoing systemic therapy, blood will be drawn at the start of therapy, during clinical follow-ups (first three), at the end of therapy, and at the first post-therapy imaging assessment. From patients undergoing surgical resection, in addition to blood, a tissue sample not required for diagnostic purposes will be obtained. If a patient undergoes a liver biopsy and consents to participate in the study, a blood sample will be collected, and a biopsy tissue sample not needed for diagnostic purposes will be obtained.
Interventions
None listed
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Primary liver cancer (hepatocellular carcinoma or intrahepatic cholangiocarcinoma) Signed informed consent Patient eligible to start first-line systemic therapy Patient eligible for surgical resection
Exclusion criteria
Concurrent conditions with a life expectancy of less than 12 months Autoimmune or chronic inflammatory diseases Substance abuse dependency Other active extrahepatic malignancies or those treated within the last 3 years, except for the following exceptions: Tumors resected with curative intent and with no evidence of disease recurrence for \>3 years prior to signing the informed consent, considered at low risk of recurrence Adequately resected non-melanoma skin cancers or lentigo maligna with no evidence of metastasis Adequately treated carcinoma in situ of the cervix with no evidence of recurrence Prostatic intraepithelial neoplasia with no evidence of infiltrative disease Adequately treated non-invasive papillary urothelial tumors or urothelial carcinoma in situ HIV infection Lack of patient cooperation or failure to sign the informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with HCC or CCA as assessed by extraction of PBMC and infiltrating cells | From enrollment to the end of treatment at 6 months | The primary objective of the study is the collection of peripheral blood samples to extract mononuclear cells and serum, as well as tissue samples to extract infiltrating cells and tumor cells. As regards the peripheral blood the extraction will be performed by Ficoll stratification. Infiltrating cells in the tissue will be isolated by enzymatic and mechanical dissociation of the tissue and centrifugation. |
Countries
Italy
Contacts
Primary ContactMario Mondelli, MD
Backup ContactStefania Mantovani, MSc
Outcome results
None listed