Advanced Therapies for Liver Metastases
Liver metastases (MTS) are the main cause of death for patients affected by colorectal carcinoma (CRC) and pancreatic ductal adenocarcinoma (PDAC), thus representing the major unmet clinical need for these malignancies. Based on preliminary and published data, the investigators hypothesize that innovative immune, gene,
| Condition(s) | Pancreatic Ductal Adenocarcinoma (PDAC), Colorectal Cancer (CRC), Liver Metastasis, IPMN, Pancreatic |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Liver metastases (MTS) are the main cause of death for patients affected by colorectal carcinoma (CRC) and pancreatic ductal adenocarcinoma (PDAC), thus representing the major unmet clinical need for these malignancies. Based on preliminary and published data, the investigators hypothesize that innovative immune, gene, and cell therapy approaches might overcome the tolerogenic liver microenvironment and represent powerful therapeutic tools for liver MTS of PDAC and CRC. The investigators have therefore planned an observational clinical study to enroll distinct cohorts of patients (i.e., metastatic CRC, preneoplastic, metastatic, and non-metastatic PDAC) and finely characterize, through integrated state-of-the-art -omics, the immune and non-immune microenvironment of their primary tumor and |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | IRCCS San Raffaele |
| Locations | Milan, Milan, Italy |
| Start date | 2019-11-06 |
| NCT ID | NCT04622423 |
| Official listing | https://clinicaltrials.gov/study/NCT04622423 |