Clinical trial NCT06899854: Collection of Blood and Tissue Samples From Patients With Primary Liver Cancer.
Official title: Collection of Blood and Tissue Samples From Patients With Primary Liver Cancer Undergoing Systemic Therapy, Surgical Resection, or Liver Biopsy.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma (HCC)
Cholangiocarcinoma
Keywords: immunotherapy
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of HCC or CCA eligible to start first-line systemic therapy

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with HCC or CCA as assessed by extraction of PBMC and infiltrating cells
timeFrame: From enrollment to the end of treatment at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo di Pavia
Study officials:
References: