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NCT06509880CompletedPhase 2/3

Immunosurveillance for Metastatic Colorectal Cancer

The Role of Neutrophil Mitochondrial Dysfunction in Medical Rehabilitation During Palliative Chemotherapy for Metastatic Colorectal Cancer

Source: ClinicalTrials.gov · Last updated 29 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
187 (actual)
First submitted
6 Jul 2024
Start date
15 Jul 2022
Primary completion date
25 Jul 2023
Lead sponsor
MIPO Clinic
NCT number
NCT06509880

What you commit to

  • Study type: Interventional · Phase 2/3
  • Participants enrolled: 187
  • From 15 Jul 2022 to the primary completion date, 25 Jul 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Who the study is looking for

  • 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.

Age in the registry: 40 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
MIPOClinic
Coordinator of this site? Confirm its status
AlmatyKazakhstanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.