Monitoring, ImmunologicPhase 2/3ISMCCNCT06509880
Immunosurveillance for Metastatic Colorectal Cancer
A Phase 2/3 study testing Adenorine and FOLFOX regimen in people with Monitoring, Immunologic, run by MIPO Clinic at 1 site in Kazakhstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Monitoring, Immunologic
- What is being tested?
- Adenorine and FOLFOX regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 187 participants
- Where
- 1 siteKazakhstan
- Study dates
- 15 Jul 2022to 30 Jul 2024
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Active pulmonary tuberculosis.
- Decompensated diabetes mellitus.
- Decompensated cardiac, vascular, pulmonary, hepatic, or renal failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Neutrophil Mitochondrial Dysfunction in Medical Rehabilitation During Palliative Chemotherapy for Metastatic Colorectal Cancer
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:
Read more
- Does adding sodium nucleinate help treatment work better?
- Does it improve quality of life (how people feel and function day to day)?
- Does it affect survival at one year?
Researchers will compare:
- FOLFOX chemotherapy plus sodium nucleinate versus
- FOLFOX chemotherapy alone
Participants will:
- Be randomly assigned (like flipping a coin) to one of the two groups;
- Receive four cycles of FOLFOX chemotherapy;
- Take sodium nucleinate daily if assigned to that group;
- Have checkups and blood tests during the study (including tumor marker blood tests such as CEA and CA 19-9);
- Complete quality-of-life questionnaires and have other planned tests that look at immune cells and how certain blood cells work;
- Be followed after treatment to see how they are doing, including up to one year after starting the study.
Read the detailed description
This randomized, single-blinded, parallel-group clinical trial was approved by the Local Ethics Committee of Kazakh National Medical University and conducted at oncology centers affiliated with university clinics in four regions of Kazakhstan. Participants had histologically confirmed metastatic colorectal cancer (T3-4 N1-2 M1). A total of 200 individuals were screened; 187 were enrolled and randomized.
Participants were allocated in a 1:1 ratio using sealed envelopes to receive either (1) FOLFOX chemotherapy plus sodium nucleinate or (2) FOLFOX chemotherapy alone. The intervention group received sodium nucleinate 50 mg per day (25 mg in the morning and 25 mg at lunch), starting 1 week before the first chemotherapy cycle and continued daily for 4 months. Both groups received four cycles of FOLFOX per institutional protocols.
Assessments included monthly clinical evaluation with general and biochemical blood tests during treatment. The following were assessed at baseline and at 1 month after completion of chemotherapy (approximately 5 months after baseline): FDG PET/CT, serum tumor markers (CEA and CA 19-9), peripheral blood immunologic status (CD4+/CD8+ ratio), and neutrophil mitochondrial activity (percentage of neutrophils with preserved mitochondrial function among 200 counted neutrophils). Baseline transthoracic echocardiography was performed to determine left ventricular ejection fraction. Health-related quality of life was assessed using the EORTC QLQ-C30 at baseline, post-treatment, and 1 year post-baseline.
Analyses were performed using Statistica 7.0 (StatSoft, USA). Continuous outcomes were compared between groups using the Mann-Whitney U test as specified in the protocol.
- Conditions
- Monitoring, Immunologic
- Being tested
- Adenorine, Placebo, FOLFOX regimen
- Keywords
- Colorectal Cancer, Chemotherapy, Rehabilitation, Mitochondria, Sodium Nucleinate
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdenorineDietary supplement
Also called natural oligodeoxynucleotide, sodium nucleinate
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.
PlaceboOther
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.
FOLFOX regimenDrug
(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)
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy according to the FOLFOX regimen in combination with sodium nucleinate | Active comparator | Patients with metastatic colorectal cancer (stages T3-4 N1-2 M1) received four courses of FOLFOX chemotherapy combined with sodium nucleinate 50 mg/day (25 mg morning, 25 mg lunch) starting 1 week before the first cycle and continued daily for four months. Receives: Dietary Supplement: Adenorine; Drug: FOLFOX regimen |
| Chemotherapy according to the FOLFOX regimen | Placebo comparator | Patients with metastatic colorectal cancer (stages T3-4 N1-2 M1) received four courses of FOLFOX chemotherapy alone. General and biochemical blood analyses were conducted monthly. Receives: Other: Placebo; Drug: FOLFOX regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Dose Intensity of FOLFOX
Relative Dose Intensity (RDI) over cycles 1-4 of FOLFOX, calculated as (delivered dose intensity / planned dose intensity) × 100. Dose intensity accounts for both dose reductions and treatment delays for oxaliplatin (mg/m²/week) and infusional 5-fluorouracil (mg/m²/week).
Measured: 1-4 cycles of FOLFOX
Secondary outcomes (7)
EORTC QLQ-C30 Global Health Status/QoL (GHS/QoL)
Global health status/quality of life subscale from the EORTC QLQ-C30. Scores are linearly transformed to a 0-100 scale. Higher scores indicate better global health status/quality of life (better outcome). Minimum = 0, maximum = 100. This is a subscale score, not a total scale score.
Measured: Baseline (before start of chemotherapy); 1 month after completion of 4 cycles (approximately 5 months after baseline); 1 year post-baseline
Mitochondrial Activity of Neutrophils
Mitochondrial activity of neutrophils assessed in peripheral blood as the percentage (%) of neutrophils with preserved mitochondrial function among 200 counted neutrophils per participant. Range 0-100%. Higher percentages indicate better preserved neutrophil mitochondrial function. Primary metric: change from baseline to 1 month after completion of chemotherapy.
Measured: Baseline (before start of chemotherapy) and post-treatment assessment 1 month after completion of chemotherapy
Positron Emission Tomography/Computed Tomography (PET/CT) Tumour Metabolic Activity
Metabolic response to treatment assessed by [18F]FDG PET/CT using EORTC PET response criteria based on the change in tumor FDG uptake (e.g., SUV metric) between baseline and follow-up. Participants were classified into mutually exclusive categories: partial metabolic response (PMR) (≥25% decrease in tumor FDG uptake), stable metabolic disease (SMD) (does not meet PMR or PMD), or progressive metabolic disease (PMD) (≥25% increase in tumor FDG uptake and/or new FDG-avid lesions). Higher metabolic activity and PMD indicate worse disease activity.
Measured: Baseline (before start of chemotherapy) and follow-up FDG-PET/CT 1 month after completion of chemotherapy (approximately 5 months after baseline).
CEA Response (≥50% Decrease From Baseline)
Serum CEA concentration measured in peripheral blood and reported in ng/mL. Higher CEA values generally indicate higher tumor burden and are used to monitor treatment response in conjunction with imaging. CEA response defined as a ≥50% decrease in serum CEA concentration from baseline to 1 month after completion of chemotherapy.
Measured: Baseline (before start of chemotherapy) and 1 month after completion of chemotherapy (approximately 5 months after baseline)
CA 19-9(Carbohydrate Antigen 19-9) Response (≥50% Decrease From Baseline)
CA 19-9 response defined as a ≥50% decrease in serum CA 19-9 concentration from baseline to 1 month after completion of chemotherapy. CA 19-9 measured in U/mL. Higher CA 19-9 values indicate higher tumor burden (worse outcome). Normal range approximately 0-27 U/mL.
Measured: Baseline (before start of chemotherapy) and 1 month after completion of chemotherapy (approximately 5 months after baseline)
CD4+/CD8+ T-Cell Ratio (Peripheral Blood)
CD4+/CD8+ T-cell ratio measured in peripheral blood (unitless ratio). The prespecified metric is the change in CD4+/CD8+ ratio from baseline to 1 month after completion of chemotherapy.
Measured: Baseline (before start of chemotherapy) and 1 month after completion of chemotherapy (approximately 5 months after baseline)
Left Ventricular Ejection Fraction (LVEF) by Echocardiography
Left ventricular ejection fraction (LVEF) ≥50% by echocardiography at baseline was required for study inclusion. Patients with LVEF <50% were excluded.
Measured: baseline (before start of chemotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start15 Jul 2022
- Primary completion25 Jul 2023
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Monitoring, ImmunologicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The primary purpose of this treatment trial is to determine whether adding sodium nucleinate mitochondrial immunotherapy to FOLFOX chemotherapy improves quality of life and reduces one-year mortality in metastatic colorectal cancer.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- MIPO Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509880
- Sponsor's protocol ID
- 3
- Acronym
- ISMCC
- Status last verified
- Jun 2026
- First submitted
- 6 Jul 2024
- Last updated
- 29 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Neutrophil Mitochondrial Dysfunction in Medical Rehabilitation During Palliative Chemotherapy for Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06509880
- Acronym / sponsor ID
- ISMCC / 3
- Conditions
- Monitoring, Immunologic
- Keywords
- Colorectal Cancer, Chemotherapy, Rehabilitation, Mitochondria, Sodium Nucleinate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- MIPO ClinicUniversity, hospital or other
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 19 Jul 2024 (actual)
- Results
- Posted 29 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does adding sodium nucleinate help treatment work better?
- Does it improve quality of life (how people feel and function day to day)?
- Does it affect survival at one year?
Researchers will compare:
- FOLFOX chemotherapy plus sodium nucleinate versus
- FOLFOX chemotherapy alone
Participants will:
- Be randomly assigned (like flipping a coin) to one of the two groups;
- Receive four cycles of FOLFOX chemotherapy;
- Take sodium nucleinate daily if assigned to that group;
- Have checkups and blood tests during the study (including tumor marker blood tests such as CEA and CA 19-9);
- Complete quality-of-life questionnaires and have other planned tests that look at immune cells and how certain blood cells work;
- Be followed after treatment to see how they are doing, including up to one year after starting the study.
Detailed description
This randomized, single-blinded, parallel-group clinical trial was approved by the Local Ethics Committee of Kazakh National Medical University and conducted at oncology centers affiliated with university clinics in four regions of Kazakhstan. Participants had histologically confirmed metastatic colorectal cancer (T3-4 N1-2 M1). A total of 200 individuals were screened; 187 were enrolled and randomized.
Participants were allocated in a 1:1 ratio using sealed envelopes to receive either (1) FOLFOX chemotherapy plus sodium nucleinate or (2) FOLFOX chemotherapy alone. The intervention group received sodium nucleinate 50 mg per day (25 mg in the morning and 25 mg at lunch), starting 1 week before the first chemotherapy cycle and continued daily for 4 months. Both groups received four cycles of FOLFOX per institutional protocols.
Assessments included monthly clinical evaluation with general and biochemical blood tests during treatment. The following were assessed at baseline and at 1 month after completion of chemotherapy (approximately 5 months after baseline): FDG PET/CT, serum tumor markers (CEA and CA 19-9), peripheral blood immunologic status (CD4+/CD8+ ratio), and neutrophil mitochondrial activity (percentage of neutrophils with preserved mitochondrial function among 200 counted neutrophils). Baseline transthoracic echocardiography was performed to determine left ventricular ejection fraction. Health-related quality of life was assessed using the EORTC QLQ-C30 at baseline, post-treatment, and 1 year post-baseline.
Analyses were performed using Statistica 7.0 (StatSoft, USA). Continuous outcomes were compared between groups using the Mann-Whitney U test as specified in the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The primary purpose of this treatment trial is to determine whether adding sodium nucleinate mitochondrial immunotherapy to FOLFOX chemotherapy improves quality of life and reduces one-year mortality in metastatic colorectal cancer.
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy according to the FOLFOX regimen in combination with sodium nucleinate | Active comparator | Dietary Supplement: Adenorine, Drug: FOLFOX regimenPatients with metastatic colorectal cancer (stages T3-4 N1-2 M1) received four courses of FOLFOX chemotherapy combined with sodium nucleinate 50 mg/day (25 mg morning, 25 mg lunch) starting 1 week before the first cycle and continued daily for four months. |
| Chemotherapy according to the FOLFOX regimen | Placebo comparator | Other: Placebo, Drug: FOLFOX regimenPatients with metastatic colorectal cancer (stages T3-4 N1-2 M1) received four courses of FOLFOX chemotherapy alone. General and biochemical blood analyses were conducted monthly. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Active pulmonary tuberculosis.
- Decompensated diabetes mellitus.
- Decompensated cardiac, vascular, pulmonary, hepatic, or renal failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdenorineAlso: natural oligodeoxynucleotide, sodium nucleinateSodium 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. | Dietary supplement | Chemotherapy according to the FOLFOX regimen in combination with sodium nucleinate |
| PlaceboMatching placebo administered orally (25 mg morning, 25 mg lunch) for four months, identical in appearance, taste, and packaging to sodium nucleinate. Contains microcrystalline cellulose. | Other | Chemotherapy according to the FOLFOX regimen |
| 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) | Drug | Chemotherapy according to the FOLFOX regimen, Chemotherapy according to the FOLFOX regimen in combination with sodium nucleinate |
Primary outcome
Relative Dose Intensity of FOLFOX
Time frame: 1-4 cycles of FOLFOX
Relative Dose Intensity (RDI) over cycles 1-4 of FOLFOX, calculated as (delivered dose intensity / planned dose intensity) × 100. Dose intensity accounts for both dose reductions and treatment delays for oxaliplatin (mg/m²/week) and infusional 5-fluorouracil (mg/m²/week).
7 secondary outcomes
EORTC QLQ-C30 Global Health Status/QoL (GHS/QoL)
Time frame: Baseline (before start of chemotherapy); 1 month after completion of 4 cycles (approximately 5 months after baseline); 1 year post-baseline
Mitochondrial Activity of Neutrophils
Time frame: Baseline (before start of chemotherapy) and post-treatment assessment 1 month after completion of chemotherapy
Positron Emission Tomography/Computed Tomography (PET/CT) Tumour Metabolic Activity
Time frame: Baseline (before start of chemotherapy) and follow-up FDG-PET/CT 1 month after completion of chemotherapy (approximately 5 months after baseline).
CEA Response (≥50% Decrease From Baseline)
Time frame: Baseline (before start of chemotherapy) and 1 month after completion of chemotherapy (approximately 5 months after baseline)
CA 19-9(Carbohydrate Antigen 19-9) Response (≥50% Decrease From Baseline)
Time frame: Baseline (before start of chemotherapy) and 1 month after completion of chemotherapy (approximately 5 months after baseline)
CD4+/CD8+ T-Cell Ratio (Peripheral Blood)
Time frame: Baseline (before start of chemotherapy) and 1 month after completion of chemotherapy (approximately 5 months after baseline)
Left Ventricular Ejection Fraction (LVEF) by Echocardiography
Time frame: baseline (before start of chemotherapy)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Adenorine and FOLFOX regimen in people with Monitoring, Immunologic, run by MIPO Clinic at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative Dose Intensity of FOLFOX (time frame: 1-4 cycles of FOLFOX). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.