Chemoembolization with Irinotecan for Colorectal Cancer with Liver Metastases

Randomized, Multicenter Phase II Study of Monoclonal FOLFOX6m + mAb Alone or in Combination With Liver Chemoembolization (Lifepearls-Irinotecan) in Patients With Colorectal Cancer and Metastatic Disease Limited to the Liver With Poor Prognosis

This study is testing a new treatment that combines a special liver chemotherapy with standard chemotherapy for people with colorectal cancer that has spread to the liver to see if it helps them respond better to treatment.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Grupo Espanol Multidisciplinario del Cancer Digestivo (other)
• Drugs / interventions: chemotherapy, Bevacizumab
• Locations: 10 sites (Sabadell, Barcelona and 9 other locations)
• Trial ID: NCT04595266 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a new treatment approach combining systemic chemotherapy with FOLFOX6m and intra-arterial liver chemotherapy using LIFEPEARLS-Irinotecan in patients with colorectal cancer that has spread to the liver. Participants will be randomly assigned to either the experimental group receiving the new treatment or a control group receiving standard chemotherapy. The primary goal is to assess the radiological response rate after six months, while secondary objectives include overall survival and safety profiles. The study aims to improve treatment outcomes for patients with poor prognostic criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with colorectal cancer and liver metastases characterized by poor prognostic factors.

Not a fit: Patients with non-colorectal cancers or those without measurable liver metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve response rates and survival for patients with advanced colorectal cancer and liver metastases.

How similar studies have performed: Previous studies have shown promising results for similar approaches using intra-arterial chemotherapy in metastatic colorectal cancer.

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

Where this trial is running

Sabadell, Barcelona and 9 other locations

• Hospital Parc Taulí — Sabadell, Barcelona, Spain (RECRUITING)
• Hospital Universitario de Alicante — Alicante, Spain (ACTIVE_NOT_RECRUITING)
• Hospital Clínic — Barcelona, Spain (RECRUITING)
• Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (RECRUITING)
• H. Univ. Ramón y Cajal — Madrid, Spain (NOT_YET_RECRUITING)
• Hospital Universitario 12 de Octubre — Madrid, Spain (RECRUITING)
• Hospital Universitario La Paz — Madrid, Spain (NOT_YET_RECRUITING)
• Complejo Hospitalario de Navarra — Pamplona, Spain (RECRUITING)
• Hospital Universitario de Canarias — Tenerife, Spain (ACTIVE_NOT_RECRUITING)
• Hospital Universitari i Politècnic La Fe — Valencia, Spain (RECRUITING)

Study contacts

• Study coordinator: Federico Nepote

Conditions: Colorectal Cancer Metastatic, Liver Metastasis Colon Cancer, Colorectal cancer, Chemoembolization, LIVERPEARLS-Irinotecan, Liver metastasis