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Chemoimmunotherapy for Colon Cancer
Study Summary
This trial will investigate if a therapy combining chemotherapy and an anti-PD-L1 mAb can improve outcomes for colon cancer patients.
Timeline
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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- I haven't had major heart problems in the last 3 months.I have not had a severe infection in the last 4 weeks.I have not had major surgery in the last 4 weeks.I have high calcium levels in my blood that are causing symptoms.I have fluid buildup due to cancer spread in my chest or abdomen.I have not taken any strong antibiotics in the last 2 weeks.I have active tuberculosis.I haven't taken any immune-boosting drugs in the last 4 weeks or 5 half-lives of the drug.I don't have any health issues that would prevent me from taking a new drug.I have had a previous transplant of stem cells or an organ.My cancer is spreading and causing symptoms or getting worse without treatment.I am currently on medication for hepatitis B.I have previously been treated with CD137 agonists or immune checkpoint inhibitors.I have had leptomeningeal disease.My tumor is located more than 12 cm from the anal opening, based on tests or surgery.I have a history of specific lung conditions not caused by known factors.I haven't taken any immune-weakening drugs in the last 2 weeks.I am over 18 years old.I am allergic to components in CAPEOX or mFOLFOX6 chemotherapy.My tumor is not MSI-high as determined by specific tests.My colon cancer is confirmed and can be surgically removed.I have not had any cancer other than colon adenocarcinoma in the last 5 years.I have or had an autoimmune disease or immune deficiency.I can provide a sample of my tumor for testing.My cancer pain is under control with a stable pain medication plan.I have not received a live vaccine in the last 4 weeks.I have one or more high-risk cancer features like high CEA, poor tumor grade, or large tumor size.My recent blood and organ function tests meet the study's requirements.I have or had more than one primary cancer in my colon or rectum.
- Group 1: Neoadjuvant Therapy Arm
- 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
Does this research trial accept participants of ages 70 and below?
"The minimum age for eligibility is 18 years, while the maximum cut-off is 80."
Are there still opportunities for participants in this experiment?
"As per the information on clinicaltrials.gov, this particular trial is no longer actively seeking participants; it was originally posted in September 1st of 2023 and last updated on May 22nd of 2023. Notwithstanding, there are still 201 other studies that require enrolment at present."
Who is qualified to partake in this research project?
"To qualify for this clinical trial, potential participants must have been diagnosed with colon cancer and be between 18 to 80 years of age. 30 individuals are needed for the study."
What are the risks associated with Neoadjuvant Therapy Arm?
"Although there is evidence that Neoadjuvant Therapy Arm may be safe, the lack of efficacy data resulted in a score of 2 on our evaluation scale."
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