CompletedPhase 2/3

Immunosurveillance for Metastatic Colorectal Cancer

Kazakhstan187 participantsStarted 2022-07-15

Plain-language summary

The goal of this clinical trial is to learn if adding sodium nucleinate to FOLFOX chemotherapy helps people with metastatic colorectal cancer (colon or rectal cancer that has spread). Researchers will also look at side effects and how people feel during treatment. The main questions this study aims to answer are: 1. Does adding sodium nucleinate help treatment work better? 2. Does it improve quality of life (how people feel and function day to day)? 3. Does it affect survival at one year? Researchers will compare: 1. FOLFOX chemotherapy plus sodium nucleinate versus 2. FOLFOX chemotherapy alone Participants will: 1. Be randomly assigned (like flipping a coin) to one of the two groups; 2. Receive four cycles of FOLFOX chemotherapy; 3. Take sodium nucleinate daily if assigned to that group; 4. Have checkups and blood tests during the study (including tumor marker blood tests such as CEA and CA 19-9); 5. Complete quality-of-life questionnaires and have other planned tests that look at immune cells and how certain blood cells work; 6. Be followed after treatment to see how they are doing, including up to one year after starting the study.

Who can participate

Age range

40 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Histologically confirmed colorectal cancer.
. Locally advanced or metastatic disease as treated with palliative FOLFOX per protocol (including metastatic disease \[M1\]).
. Able to receive FOLFOX chemotherapy and to comply with study procedures.
. Provided written informed consent.

Exclusion criteria

. Active pulmonary tuberculosis.
. Decompensated diabetes mellitus.
. Decompensated cardiac, vascular, pulmonary, hepatic, or renal failure.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Relative Dose Intensity of FOLFOX

Timeframe: 1-4 cycles of FOLFOX

Trial details

NCT IDNCT06509880

SponsorMIPO Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-25

Results submitted2026-04-20

View on ClinicalTrials.gov More Monitoring, Immunologic trials