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Ablative Therapy + Systemic Therapy for Colorectal Cancer
Study Summary
This trial compares using intense local treatment to the usual approach of using only intravenous and/or oral medications to treat colorectal cancer spread to up to 4 sites.
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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Who is running the clinical trial?
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- My cancer did not worsen while on my last treatment.My primary tumor has been removed or can be surgically removed.My cancer does not have the BRAF V600E mutation.I am able to get out of my bed or chair and move around.I am HIV-positive, on treatment, and my viral load is undetectable.I am 18 years old or older.My tumor is not MSI-high.My brain cancer has not worsened after treatment.My cancer has not spread to the lining of my abdomen or the fat layer.My cancer has spread to 4 or fewer places in my body.I have had up to 4 months of systemic therapy before joining.My cancer is a type of colorectal cancer that has spread.My kidney function, measured by creatinine levels, is within the normal range.I've been on first-line treatment for my metastatic disease for 4 to 6 months.My last cancer treatment was over a year ago before my cancer spread.I am not a candidate for or unsure of the benefits from HAIP therapy.My cancer that has spread can be treated with surgery or targeted therapies.
- Group 1: Arm 1 (TAT, SOC chemotherapy
- Group 2: Arm 2 (SOC chemotherapy)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
In how many venues is this research project being conducted?
"Currently, 11 physical trial sites are available to participate in this clinical study. These locations range from Gainesville to Des Moines and everywhere in between. It is recommended for participants to choose the site closest geographically so as not to overextend themselves with too much travel."
What potential risks can be associated with Arm 1 (TAT, SOC chemotherapy)?
"Arm 1 (TAT, SOC chemotherapy) has a safety rating of 3 due to the prior research data illustrating its efficacy and multiple rounds proving its security."
Are there any openings for participants in this exploration?
"Confirmed. Clinicaltrials.gov reveals that this medical research, which was first listed on October 1st 2023, is currently in the process of recruiting participants. A total of 364 individuals are needed from 11 different facilities."
How many people are currently participating in the research program?
"Correct. The clinical trial's posting on clinicialtrials.gov confirms that it is presently accepting patients. This research project was initially posted on 10th of January 2023 and its most recent edit was conducted in April 14th 2023, with the aim to recruit 364 individuals from 11 distinct medical centres."
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