Hepatocellular Carcinoma (HCC)NCT06899854
Collection of Blood and Tissue Samples From Patients With Primary Liver Cancer.
An observational study of Hepatocellular Carcinoma (HCC) and Cholangiocarcinoma, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Cholangiocarcinoma
- How many people
- 53 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jun 2023to 1 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosis of HCC or CCA eligible to start first-line systemic therapy
Who may be able to join
- Primary liver cancer (hepatocellular carcinoma or intrahepatic cholangiocarcinoma)
- Signed informed consent
- Patient eligible to start first-line systemic therapy
- Patient eligible for surgical resection
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Stefania Mantovani, MSc contact
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Pavia, 27100
Mario Mondelli, MD, m.mondelli@smatteo.pv.it
Stefania Mantovani, Biologist, s.mantovani@smatteo.pv.it
About this study
Official title: Collection of Blood and Tissue Samples From Patients With Primary Liver Cancer Undergoing Systemic Therapy, Surgical Resection, or Liver Biopsy.
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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma (HCC), Cholangiocarcinoma
- Keywords
- immunotherapy
- Medical subject headings
- Carcinoma, Hepatocellular, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with HCC | Patients with a diagnosis of HCC | |
| Patients with CCA | Patients with a diagnosis of CCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with HCC or CCA as assessed by extraction of PBMC and infiltrating cells
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.
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start19 Jun 2023
- Primary completion19 Mar 2025
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Mondelli, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899854
- Sponsor's protocol ID
- p_129_2023
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Blood and Tissue Samples From Patients With Primary Liver Cancer Undergoing Systemic Therapy, Surgical Resection, or Liver Biopsy.
- ClinicalTrials.gov ID
- NCT06899854
- Acronym / sponsor ID
- p_129_2023
- Conditions
- Hepatocellular Carcinoma (HCC), Cholangiocarcinoma
- Keywords
- immunotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with HCC | – | –Patients with a diagnosis of HCC |
| Patients with CCA | – | –Patients with a diagnosis of CCA |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of HCC or CCA eligible to start first-line systemic therapy
Key inclusion criteria (4 listed)
- Primary liver cancer (hepatocellular carcinoma or intrahepatic cholangiocarcinoma)
- Signed informed consent
- Patient eligible to start first-line systemic therapy
- Patient eligible for surgical resection
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with HCC or CCA as assessed by extraction of PBMC and infiltrating cells
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefania Mantovani, MSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma (HCC) and Cholangiocarcinoma, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mario Mondelli, MD (0382501808, mario.mondelli@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with HCC or CCA as assessed by extraction of PBMC and infiltrating cells (time frame: From enrollment to the end of treatment at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.