Study on the Safety and Feasibility of Delivering Chemotherapy Directly to the Liver for Patients with Liver Cancer

Sponsor: Michael J Cavnar, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07201519

Provider View

This clinical trial is exploring a new way to deliver chemotherapy directly to the liver for patients with liver cancer that has spread from the colon or rectum, or for those with a specific type of liver cancer called intrahepatic cholangiocarcinoma. The study will test the safety of using a pump to deliver the treatment and whether it can be done at home or a local clinic instead of a hospital.

Patient Parameters

Program Overview

The purpose of this study is to find out if using a pump to deliver chemotherapy directly to the liver is safe and practical for patients with liver cancer. This includes patients whose cancer has spread to the liver from the colon or rectum, or those with a type of liver cancer called intrahepatic cholangiocarcinoma. The study will also look at whether patients can safely have their pump refilled at home or a local clinic instead of always going to the hospital. Participants will have surgery to install the pump, which is a standard procedure. After surgery, they can choose to receive treatment at the hospital or with a local cancer doctor. The main treatment will last about 3-4 months.

Eligibility Criteria

Inclusion Criteria

  • Have colorectal cancer that has spread to the liver, which may or may not be removable by surgery, or have a specific type of liver cancer called intrahepatic cholangiocarcinoma that cannot be removed by surgery.
  • Be 18 years or older.
  • Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have specific blood test results within normal ranges, including:
    • Neutrophil count of at least 1,500/mcL.
    • Total bilirubin of 1.5 mg/dL or less.
    • AST/ALT levels less than 5 times the upper limit of normal.
    • Platelet count of at least 100,000/mcL.
    • Creatinine level of 1.5 mg/dL or less.
    • Hemoglobin level of at least 8 g/dL.
    • INR of 1.5 or less.
  • HIV-positive patients on effective treatment with undetectable viral load are eligible.
  • Patients with hepatitis B or C must have undetectable viral loads if on treatment.
  • Must have completed any prior chemotherapy at least 3 weeks before joining the study.
  • Must have completed any investigational treatment at least 3 months before joining the study.
  • Must be able to do telehealth visits if choosing treatment with a local oncologist.

Exclusion Criteria

  • Have cancer that has spread beyond the liver, except for certain conditions that can be treated.
  • Have specific genetic conditions like microsatellite instability or mismatch repair deficiency.
  • Have had prior radiation treatment to the liver.
  • Cannot take the drug Bevacizumab (Avastin®) with the study treatment unless there is a 6-week gap.
  • Have active infections or liver-related conditions like hepatic encephalopathy.
  • Have signs of portal hypertension, such as fluid buildup in the abdomen or enlarged veins in the esophagus.
  • Be pregnant or breastfeeding, or planning to become pregnant within 6 months after treatment.
  • Have serious medical conditions that may interfere with treatment.
  • Have a history of brain tumors, uncontrolled seizures, or recent stroke.
  • Have serious wounds or fractures that are not healing.
  • Have other cancers that may interfere with the study treatment.
  • Have psychiatric or social issues that may affect participation.
  • Cannot commit to traveling to treatment locations every 2 weeks for 6 months.
  • Have certain medical devices that may interfere with the study treatment, unless specific conditions are met.

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