Testing Pump Chemotherapy Alongside Standard Chemotherapy for Patients with Unremovable Colorectal Cancer Spread to the Liver: The PUMP Trial

Sponsor: ECOG-ACRIN Cancer Research Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05863195

Provider View

This study is comparing the effects of adding pump chemotherapy to standard chemotherapy versus using standard chemotherapy alone in patients with colorectal cancer that has spread to the liver and cannot be surgically removed.

Patient Parameters

Program Overview

This trial is exploring whether adding a special type of chemotherapy, called hepatic arterial infusion (HAI), to the usual chemotherapy can help treat colorectal cancer that has spread to the liver and cannot be removed by surgery. HAI delivers a chemotherapy drug directly to the liver through a pump, which is already approved for use but not widely available. The study aims to see if this combination can better shrink or control the cancer compared to standard chemotherapy alone.

Description

The main goal of this study is to find out if patients with colorectal cancer that has spread to the liver and cannot be removed by surgery live longer when treated with both pump chemotherapy (HAI) and standard chemotherapy, compared to standard chemotherapy alone.

Secondary goals include:

  • Checking if the combination of HAI and standard chemotherapy helps control cancer in the liver and overall better than chemotherapy alone.
  • Measuring how many patients' liver tumors shrink or become manageable enough for surgery.
  • Understanding how often patients planned for HAI become ineligible due to other health issues found during surgery.
  • Identifying factors that might increase the risk of complications from HAI.

Participants are divided into two groups:

  • Group A: Patients will have surgery to place the HAI pump and receive chemotherapy directly to the liver, along with standard chemotherapy drugs. They will also have regular CT scans.
  • Group B: Patients will receive standard chemotherapy drugs and regular CT scans, without the HAI pump.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have colorectal cancer that has spread to the liver and cannot be removed by surgery.
  • No signs of cancer outside the liver, except for certain small lung nodules.
  • Have received 3-6 months of initial chemotherapy.
  • Cancer must be stable or responding to initial chemotherapy.
  • Must meet specific criteria showing surgery is not possible.
  • Must have a CT scan to confirm liver anatomy is suitable for HAI.
  • Must be in good health to undergo surgery.
  • Meet specific blood and organ function requirements.
  • HIV-positive patients can participate if their viral load is controlled.
  • Must not have other health conditions that interfere with the study.

Exclusion Criteria

  • Liver tumors must not cover more than 70% of the liver.
  • No previous liver radiation or certain liver treatments.
  • No previous treatment with HAI or floxuridine.
  • Must not have a specific genetic type of colorectal cancer (MSI-H).
  • Must not have liver metastases that could be removed with a specific surgical technique.
  • No active infections or serious medical conditions.
  • Must not have liver cirrhosis or signs of high blood pressure in the liver.
  • Must not be pregnant or breastfeeding.
  • Must agree to use effective birth control during the study.

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