← Back to all trials
Recruiting
NCT07764497
Hepatic Arterial Infusion Chemotherapy in Patients With Inoperable Colorectal Cancer Liver Metastasis
Conditions: Colorectal Adenocarcinoma Metastatic in the Liver, Liver Metastasis Colon Cancer, Liver Metastases From Colorectal Cancer, Liver Metastases of Colorectal Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 200
Sponsor: Sunnybrook Health Sciences Centre
Location: Sunnybrook Health Sciences Centre Toronto Ontario
Summary
The goal of this clinical trial is to assess how many patients with initially inoperable colorectal liver metastasis are able to have a liver surgery after treatment with hepatic artery infusion chemotherapy and standard of care systemic chemotherapy.
Eligibility Criteria
Inclusion Criteria:
1. History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease. Patients with resectable or ablatable lung metastasis are eligible.
2. Physically able to tolerate major partial hepatectomy.
3. The primary tumor may be in place at the time of registration if not obstructing the intestinal lumen or significantly bleeding. If present, the primary tumor will be resected at the time of pump placement.
4. Chest, Abdominal and Pelvic CT scan with CT angiogram within 6 weeks prior to registration. (MRI angiogram with contrast of the abdomen may be substituted for CT of the abdomen).
5. The patient must have inoperable liver metastases as agreed upon by any two hepatobiliary surgeons and the assigned radiologist. In the event that two hepatobiliary surgeons cannot agree, a third surgeon will be consulted. Continued discrepancy will result in the patient's case being presented at weekly hepatobiliary conference for consensus opinion. Inoperable metastases are defined as: requiring a resection that leaves less than 2 hepatic segments (not including the caudate lobe) behind with adequate arterial/portal inflow, venous outflow and biliary drainage. \* A patient is considered resectable if the procedure includes a minor wedge or thermo-ablation encompassing 10% or less of the volume of the remaining 2 segments.
6. Patient's liver metastases must comprise \3X10E9/L; ANC ≥ 1.5X10E9/L; Platelet count \>100X10E9/L; INR \< 1.5; HGB ≥ 90 g/L; Estimated creatinine clearance ≥30 ml/min (using Cockcroft and Gault formula); Total serum bilirubin \
Source: ClinicalTrials.gov (NCT07764497). StuddyBuddy aggregates publicly available trial information.