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

Launched by GRUPO ESPANOL MULTIDISCIPLINARIO DEL CANCER DIGESTIVO · Oct 19, 2020

Keywords

ClinConnect Summary

The clinical trial titled "Chemoembolization (Lifepearls-Irinotecan) in Patients With Colorectal Cancer and Metastatic Disease" is studying a new treatment approach for patients with colorectal cancer that has spread to the liver. In this trial, participants will be divided into two groups: one group will receive standard chemotherapy, while the other group will receive the same chemotherapy along with a special treatment that delivers medication directly into the liver. The main goal of the study is to see how well these treatments work in shrinking tumors in the liver after six months.

To be eligible for the trial, patients must be at least 18 years old and have colorectal cancer with liver metastases. They should have measurable disease and certain blood test results that show their liver and bone marrow are functioning well. The trial is currently recruiting participants, and those who join can expect to be monitored closely for their health and response to treatment. It’s important to note that there are specific health conditions that could prevent someone from participating, such as significant heart problems or other serious illnesses. Participants will be informed about all procedures and must provide written consent to join the study.

Gender

ALL

Eligibility 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 \<1.5 mg / dL. Blood Ureic Nitrogen (BUN)\> 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:
• • 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