Program Status
Active, not recruitingPhase
Phase 2Prior Immunotherapy Allowed
NoCRC-directed Trial
YesDrugs
Anti-EGFR or Bevacizumab, FOLFOX regimen, LIVERPEARLS-IrinotecanTags
MSI-H/ MMRd, MSS/ MMRp| Location | Location Status |
|---|---|
| Spain | |
|
Hospital Clínic Barcelona, Barcelona |
Active, not recruiting |
|
Hospital de la Santa Creu i Sant Pau Barcelona, Barcelona |
Active, not recruiting |
|
Hospital Parc Taulí Sabadell, Barcelona |
Active, not recruiting |
|
H. Univ. Ramón y Cajal Madrid, Madrid 28044 |
Active, not recruiting |
|
Hospital Universitario 12 de Octubre Madrid, Madrid |
Active, not recruiting |
|
Hospital Universitario La Paz Madrid, Madrid |
Active, not recruiting |
|
Complejo Hospitalario de Navarra Pamplona, Pamplona |
Active, not recruiting |
|
Hospital Universitari i Politècnic La Fe Valencia, Valencia 46026 |
Active, not recruiting |
Inclusion Criteria
Inclusion Criteria:
* Patients aged ≥ 18 years.
* Patients with colorectal cancer and exclusive liver metastases with poor prognostic criteria,> 3 lesions and / or size> 5 cm. Patients with a diagnosis of liver metastases with synchronous presentation or with a disease-free interval may be included. If the primary tumor has not been resected, it must be clinically stable.
* Measurable disease following RECIST version 1.1 criteria
* Adequate bone marrow function, according to:
1. Hemoglobin ≥ 9.0 g / dl (patients with hemoglobin <9 g / dl can be transfused before inclusion in the study
2. Platelet count ≥ 100 x 109 / L
3. Absolute Neutrophil Count (ANC) ≥ 1.5x 109 / L
* Adequate liver function, according to:
1. Serum bilirubin ≤ 1.5 x the upper limit of normal (ULN)
2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.
3. Alkaline phosphatase ≤ 5 x ULN or ≤10 x ULN in the presence of bone metastases
4. Adequate renal function, with creatinine levels 50 ml / min.
5. Albumin> 3.0 g / dL
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
* Patients capable of understanding the information and giving their written informed consent to participate in the study
* Women of childbearing potential must commit to sexual abstinence or use of barrier contraceptive methods during the study and must have a negative pregnancy test.
Exclusion Criteria
Exclusion Criteria:
* Extension of the disease> 50% of the liver parenchyma (evaluated by CT performed within the month prior to inclusion)
* Previous chemotherapy treatment for metastatic colorectal cancer
* Clinically significant cardiovascular diseases: cerebrovascular accident / stroke (≤ 6 months before inclusion in the trial), myocardial infarction (≤ 6 months before inclusion in the trial), unstable angina, uncontrolled hypertension, congestive heart failure of New York Heart Association (NYHA) grade II or higher or severe cardiac arrhythmia.
* History of malignancy in the last three years, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix treated appropriately.
* Altered coagulation (Quick> 50%)
* Patients with active infectious processes
* Patients with any of the contraindications specified in the technical data sheet of the study drug or with allergies to some of the drugs used
* Pregnant or lactating patients
* Portal thrombosis
* Severe portal hypertension
* Extrahepatic metastases
