Immunosurveillance for Metastatic Colorectal Cancer

NCT06509880 | Completed Phase 2 Results DMC

• 1 other identifier: 3
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does adding sodium nucleinate help treatment work better?
2. 2.Does it improve quality of life (how people feel and function day to day)?
3. 3.Does it affect survival at one year?
4. 4.FOLFOX chemotherapy plus sodium nucleinate versus
5. 5.FOLFOX chemotherapy alone
6. 6.Be randomly assigned (like flipping a coin) to one of the two groups;
7. 7.Receive four cycles of FOLFOX chemotherapy;
8. 8.Take sodium nucleinate daily if assigned to that group;
9. 9.Have checkups and blood tests during the study (including tumor marker blood tests such as CEA and CA 19-9);
10. 10.Complete quality-of-life questionnaires and have other planned tests that look at immune cells and how certain blood cells work;
11. 11.Be followed after treatment to see how they are doing, including up to one year after starting the study.

Conditions

Monitoring, Immunologic

Keywords

Colorectal Cancer; Chemotherapy; Rehabilitation; Mitochondria; Sodium Nucleinate

Outcome Measures

Primary Outcomes (1)

• 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).

  1-4 cycles of FOLFOX

Secondary Outcomes (7)

• EORTC QLQ-C30 Global Health Status/QoL (GHS/QoL)

  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

  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

  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)

  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)

  Baseline (before start of chemotherapy) and 1 month after completion of chemotherapy (approximately 5 months after baseline)

Study Arms (2)

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.

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.

Other: Placebo; Drug: FOLFOX regimen

Interventions

Adenorine DIETARY_SUPPLEMENT

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.

Also known as: natural oligodeoxynucleotide, sodium nucleinate

Chemotherapy according to the FOLFOX regimen in combination with sodium nucleinate

Placebo OTHER

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.

Chemotherapy according to the FOLFOX regimen

FOLFOX regimen DRUG

(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)

Chemotherapy according to the FOLFOX regimen; Chemotherapy according to the FOLFOX regimen in combination with sodium nucleinate

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• MIPO Clinic: lead

Study Sites (1)

MIPOClinic

Almaty, Almaty, 050038, Kazakhstan

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

sodium nucleinate; Folfox protocol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Limitations and Caveats

Single-center study. Participants blinded (placebo-controlled), treating clinicians not blinded. Chemotherapy dose modifications governed by objective criteria with blinded adjudication. Follow-up limited to 12 months. Age restricted to 40-65 years.

Results Point of Contact

• Title: Stanislav Alexandrovich Panov, MD
• Organization: Military Clinical Hospital of the Ministry of Defense of the Republic of Kazakhstan

panov_stanislav@mail.ru

+7-747-682-6613

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomization 1:1 using computer-generated block randomization with variable block sizes, stratified by ECOG status, metastatic sites, and prior adjuvant chemotherapy. Allocation concealment: sequentially numbered, opaque, sealed envelopes (SNOSE); randomization table not disclosed to researchers. Blinded outcome assessors: intake nurse, lab technician, researcher performing measurements, social worker processing QoL questionnaires, and statistician (Group A/B until database lock). Treating clinicians were not blinded. All chemotherapy dose modifications (delays, reductions, cancellations) were governed by protocol-defined objective criteria (e.g., ANC \<1000/mm³, platelets \<50,000/mm³, CTCAE grade ≥3) with no investigator discretion. A blinded Endpoint Adjudication Committee reviewed 100% of modifications to verify adherence to objective criteria. Treating physician had no access to functional blood tests or QoL results during treatment; outcomes entered after treatment course compl
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2024
• First Posted: July 19, 2024
• Study Start: July 15, 2022
• Primary Completion: July 25, 2023
• Study Completion: July 30, 2024
• Last Updated: June 29, 2026
• Results First Posted: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)