Program Status
RecruitingPhase
Phase 2Prior Immunotherapy Allowed
NoCRC-directed Trial
YesDrugs
Anti-EGFR or Bevacizumab, FOLFOX regimen, LIVERPEARLS-IrinotecanTags
MSI-H/ MMRd, MSS/ MMRpLocation | Location Status |
---|---|
Spain | |
Hospital Parc Taulí Sabadell, Barcelona |
Recruiting |
Hospital Universitario de Alicante Alicante |
Active, not recruiting |
Hospital Clínic Barcelona |
Recruiting |
Hospital de la Santa Creu i Sant Pau Barcelona |
Recruiting |
H. Univ. Ramón y Cajal Madrid 28044 |
Not yet recruiting |
Hospital Universitario 12 de Octubre Madrid |
Recruiting |
Hospital Universitario La Paz Madrid |
Not yet recruiting |
Complejo Hospitalario de Navarra Pamplona |
Recruiting |
Hospital Universitario de Canarias Tenerife |
Active, not recruiting |
Hospital Universitari i Politècnic La Fe Valencia 46026 |
Recruiting |
Contacts
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:
Hemoglobin ≥ 9.0 g / dl (patients with hemoglobin <9 g / dl can be transfused before inclusion in the study
Platelet count ≥ 100 x 109 / L
Absolute Neutrophil Count (ANC) ≥ 1.5x 109 / L
Adequate liver function, according to:
Serum bilirubin ≤ 1.5 x the upper limit of normal (ULN)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.
Alkaline phosphatase ≤ 5 x ULN or ≤10 x ULN in the presence of bone metastases
Adequate renal function, with creatinine levels 50 ml / min.
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