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HAIP Chemotherapy for Metastatic Colorectal Cancer
Study Summary
This trial is for people with colorectal cancer that has spread to their liver. It is testing if a pump that gives chemotherapy drugs directly to the liver for 2 weeks at a time is effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- My liver cancer can be surgically removed until there's no visible disease.Your arteries, as seen on a special type of scan called CT angiogram, should be suitable for placing a device called HAIP (hepatic artery infusion pump).You have had allergic reactions to medicines that are similar to FUDR or heparin.My diagnosis is colorectal adenocarcinoma confirmed by lab tests.My cancer did not respond or worsened after treatment with specific chemotherapy drugs.I agree to use birth control during and after the study due to the risk of birth defects from the treatment.My lung cancer has less than 5 large tumors, stable for 4 months, and can be surgically removed if needed.I had surgery to remove cancer outside my liver and was cancer-free for 4 months or less.I have MSI-high cancer and need treatment with checkpoint inhibitors.I have not had any cancer other than colorectal, basal cell skin, or thyroid in the last 5 years.I am not pregnant or breastfeeding if I want to participate in this study.I am 18 years old or older.I do not have any serious illnesses that my doctor thinks could make this study unsafe for me.I do not have an active Hepatitis B or C infection.I am fully active or have some restrictions but can still care for myself.I have had radiation therapy to my liver.You are currently taking experimental drugs for other medical conditions.My organs and bone marrow are working well.My cancer has spread beyond my colon/rectum and liver, making liver-focused treatments unlikely to help.I have cancer that has spread to my liver and it can be measured.My kidney function tests are within normal range.
- Group 1: 1/ Arm 1
Frequently Asked Questions
Are there any life-threatening risks associated with cetuximab?
"There is some clinical data suggesting that cetuximab is safe, but none demonstrating its efficacy. It received a score of 2."
Are there any available vacancies for participants in this experiment?
"That is correct. The information available on clinicaltrials.gov supports that this trial is currently looking for patients. This study was originally posted on June 24th, 2019 and has been updated as recently as October 20th, 2020. Currently, the plan is to have 40 participants across 1 site."
To what extent has cetuximab been researched in the past?
"Cetuximab is being studied in 661 live trials, with 178 of those studies in Phase 3. Guangzhou, Guangdong has several cetuximab studies running, but there are 23986 locations worldwide where the medication is being trialed."
How many people are being included in this trial?
"The data on clinicaltrials.gov indicates that this study is currently recruiting participants. The trial was first posted on 6/24/2019 and was last edited on 10/20/2022. The clinical trial is recruiting for 40 participants across 1 sites."
What are the conditions that cetuximab is designed to improve?
"cetuximab, which is used to treat colorectal carcinoma, can also be employed against other diseases such as ovarian cancer and squamous cell carcinoma."
What benefits are researchers looking for in this clinical trial?
"The primary metric of success for this clinical trial will be Response rate (RR), with data being collected over the course of the study's progression. Additionally, secondary measures of success include Overall survival, Extra-hepatic progression free survival, and Hepatic progression-free survival."
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