Innovative therapies for liver metastases in cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on patients with metastatic colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) who have liver metastases, which are a leading cause of cancer-related death. The study aims to enroll distinct cohorts of patients and utilize advanced -omics technologies to characterize the immune and non-immune microenvironment of their tumors and liver metastases. By analyzing changes in the activation status of peripheral blood leukocytes, the researchers hope to identify potential therapeutic targets and improve treatment strategies for these patients. Healthy volunteers will also be included as negative controls to provide comparative data.

Why it matters

Who can join: the full rules

Inclusion and exclusion criteria - CRC patients

Inclusion criteria:

1. Patients with histologically or cytologically confirmed diagnosis of CRC metastatic to the liver (stage IV disease, AJCC)
2. Patients with indication to surgical resection and/or chemotherapy treatment
3. Age ≥18
4. ECOG PS 0-1 at enrollment
5. Written informed consent
6. Patients will be treated in IRCCS San Raffaele

Exclusion criteria:

1. Pregnancy or lactation
2. Inability to provide a written informed consent
3. Extraepatic disease with the exception of selected cases in which the coexistence of extrahepatic disease does not constitute an exclusion criterion for hepatic resective surgery (for example in patients with extraepatic lesions in remission or in any case stabilized by chemotherapy)
4. Severe comorbidities (e.g. cardiac diseases, history of psychiatric disabilities, HIV, autoimmune disorders)
5. Concurrent or previous other malignancy within 5 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, or other noninvasive or indolent malignancy
6. Other conditions (medical or psychiatric) that in the judgment of Investigators would make the patient an inappropriate candidate for the study

Inclusion and exclusion criteria - PDAC patients

Inclusion criteria:

1. Patients with clinical/radiological diagnosis/suspicious of pancreatic adenocarcinoma metastatic to the liver, with subsequent cytological/histological confirmation (stage IV disease, AJCC)
2. Age ≥18
3. Karnofsky performance status ≥50
4. Metastatic pancreatic adenocarcinoma patients with histological specimens from whole liver metastasis biopsy or core liver biopsy collected at IRCCS San Raffaele and stored in the institutional biobank Centro Risorse Biologiche (CRB-OSR)
5. Written Informed consent
6. Patients with clinical/radiological diagnosis of not metastatic primary PDAC that will undergo pancreatic resection at IRCCS San Raffaele

Exclusion criteria:

1. Severe comorbidities (e.g., cardiac diseases, history of psychiatric disabilities) representing an absolute contraindication for whole or core liver metastasis biopsy
2. Pregnancy or lactation
3. Inability to provide a written informed consent
4. Metastatic pancreatic adenocarcinoma patients enrolled in other research trials entailing the analysis of the liver metastasis histological sample

Where it's running

• IRCCS San Raffaele
  Milan, Milan, Italy Recruiting

Study contacts

• Principal investigator: Chiara Bonini, MD — Vita-Salute San Raffaele University, IRCCS San Raffaele
• Study coordinator: Chiara Bonini, MD
• Email: bonini.chiara@hsr.it
• Phone: 0226434790

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.