Study on M9241 with Liver-Directed Chemotherapy and Systemic Therapy for Patients with Liver Metastases from Colorectal Cancer or Bile Duct Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT05286814
This clinical trial is exploring whether adding the drug M9241 to liver-directed chemotherapy can improve treatment for patients with colorectal cancer that has spread to the liver or bile duct cancer confined to the liver. M9241 is designed to boost the immune system's ability to fight cancer.
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Program Overview
This study is testing a new approach to treating liver cancer by delivering chemotherapy directly to the liver using a special pump, combined with a drug called M9241 that activates the immune system. The goal is to see if this combination is effective for patients with colorectal cancer that has spread to the liver or bile duct cancer that is only in the liver. Participants will undergo surgery to place a pump that delivers chemotherapy directly to the liver, receive M9241 injections, and have regular check-ups to monitor their health and the treatment's effects.
Description
This study is investigating a new treatment method for liver cancer that involves delivering chemotherapy directly to the liver through a pump, combined with a drug called M9241 that helps the immune system fight cancer. The treatment aims to improve outcomes for patients with colorectal cancer that has spread to the liver or bile duct cancer confined to the liver.
Participants will undergo surgery to place a catheter in an artery that supplies blood to the liver. This catheter will be connected to a pump placed under the skin, which will deliver chemotherapy directly to the liver every two weeks. Additionally, participants will receive M9241 injections under the skin every four weeks and systemic chemotherapy through an IV every two weeks.
The study will monitor participants' response to the treatment, including regular CT scans every eight weeks and other health checks. Participants will continue the treatment until their cancer worsens or they experience significant side effects. After completing the treatment, participants will have a follow-up visit and will be contacted every six months for five years to track their health.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for three months after.
- Men must agree to use effective birth control during the study and for three months after.
- Must be able to undergo surgery to place the liver pump.
- Must sign an informed consent form.
- HIV-positive participants can join if their viral load is undetectable.
- Must agree to participate in a related tissue collection study.
- Liver metastases must not be removable by surgery.
- Must be able to tolerate systemic chemotherapy.
For Colorectal Cancer:
- Must have colorectal cancer that has spread to the liver.
- Must have measurable liver tumors.
- Must have received first-line chemotherapy.
- Must have good organ and bone marrow function.
For Bile Duct Cancer:
- Must have bile duct cancer confined to the liver.
- Must have measurable disease that cannot be surgically removed.
- Must have received first-line chemotherapy.
- Must have good organ and bone marrow function.
Exclusion Criteria
- Cannot be receiving other experimental treatments.
- Cannot have received rIL-12 before.
- Cannot have active autoimmune diseases, except for certain conditions like type I diabetes or thyroid disorders.
- Cannot have had an organ transplant requiring immunosuppression.
- Cannot have inflammatory bowel disease.
- Cannot have allergies to similar drugs used in the study.
- Cannot have significant heart disease or recent heart attack.
- Cannot have active ulcers or bowel disease.
- Cannot have other active cancers within the last five years, except for certain skin or thyroid cancers.
- Cannot have had prior liver radiation.
- Cannot have active Hepatitis B or C.
- Cannot have significant infections or tuberculosis.
For Colorectal Cancer:
- Cannot have cancer outside the liver and colon/rectum, except for certain lung lesions.
- Cannot have had extra-hepatic metastasectomy with a short disease-free interval.
- Cannot need treatment with checkpoint inhibitors.
- Cannot have had prior FUDR treatment.
For Bile Duct Cancer:
- Cannot have distant metastatic disease, except for certain lung lesions.
- Cannot have had prior FUDR treatment.
- Cannot have sclerosing cholangitis.
- Cannot have signs of portal hypertension.
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