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Immunosurveillance for Metastatic Colorectal Cancer

NCT06509880 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 187

Last updated 2026-06-29

Study results available
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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.

Conditions

  • Monitoring, Immunologic

Interventions

DIETARY_SUPPLEMENT

Adenorine

Sodium nucleinate (Adenorine) is an immunomodulatory oligonucleotide preparation. In this trial, it was administered orally at 50 mg per day (25 mg in the morning and 25 mg at lunch before meals) for four months, starting 7 days before the first cycle of FOLFOX chemotherapy.

OTHER

Placebo

Matching placebo administered orally (25 mg morning, 25 mg lunch) for four months, identical in appearance, taste, and packaging to sodium nucleinate. Contains microcrystalline cellulose.

DRUG

FOLFOX regimen

(Day 1-2: Oxaliplatin 100 mg/m2 IV infusion, given as a 120 minutes IV infusion in 500 mL D5W, concurrent with leucovorin 400 mg/m2 (or levoleucovorin 200 mg/m2) IV infusion, followed by 5-FU 400 mg/m2 IV bolus, followed by 46-hour 5-FU infusion (2400 mg/m2 for first two cycles, and may be increased to 3000 mg/m2 if tolerated by patient (no toxicity \> grade 1 during the first two cycles), days 3-14: Rest days)

Sponsors & Collaborators

  • MIPO Clinic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-15
Primary Completion
2023-07-25
Completion
2024-07-30

Countries

  • Kazakhstan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06509880 on ClinicalTrials.gov