Chemoembolization (Lifepearls-Irinotecan) in Patients With Colorectal Cancer and Metastatic Disease

Program Status

Recruiting

Phase

Phase 2

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Drugs

Anti-EGFR or Bevacizumab, FOLFOX regimen, LIVERPEARLS-Irinotecan

Tags

MSI-H/ MMRd, MSS/ MMRp
Location 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

Federico Nepote
Contact
934344412 investigacion@mfar.net
Verónica Roca
Contact
934344412 investigacion@mfar.net

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

NCT ID

NCT04595266

Date Trial Added

2020-10-20

Updated Date

2024-04-10