Immunosurveillance for Metastatic Colorectal Cancer

NCT ID: NCT06509880

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2024-07-31

Brief Summary

The goal of this study type: clinical trial is to primary purpose: e.g., learn if intervention or health behavior can treat, prevent, diagnose etc. and improve the quality of life and reduce one-year mortality in palliative treatment of metastatic forms of colorectal cancer.. The main question[s] it aims to answer [is/are]:

1. Does the combination of sodium adenosine nucleonate and FOLFOX course affect chemotherapy efficacy and treatment adherence?

2. which of the assays can be considered a marker of the efficacy of the combination of sodium nucleonate and FOLFOX?

3. Effect of the combination of adenosine nucleonate sodium and FOLFOX on patient quality of life?

• If there is a comparison group:_ Researchers will compare [compare the two arms of the main arm 100 patients and the control arm 100 patients] to see if [insert effects].

Participants will [describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items].

1. To evaluate the efficacy of palliative care with 4 courses of FOLFOX-based chemotherapy combined with sodium nucleonate for metastatic colorectal cancer (CRC) in the main group.

2. In the control group in metastatic colorectal cancer to study the efficacy of 4 courses of stand-alone standard chemotherapy according to the FOLFOX scheme.

3. To examine the obtained results and compare the quality of life, dynamics of laboratory tests and overall survival in the main and control groups.

4. To evaluate the influence of quantitative and qualitative indices of mitochondrial activity in the blood of patients in the main and control groups.

5. To reveal the correlation between the dynamics of mitochondrial dysfunction, quality of life of patients, tolerance to toxic effects of chemotherapy, as well as the reduction of one-year mortality in patients with colorectal cancer.

Detailed Description

Materials and methods of the study. According to the approved by the Local Ethical Committee of the Kazakh National Medical University, it was planned to include in the study 200 patients from 19 regions of Kazakhstan with histological, verified diagnosis of "colorectal cancer", treated in oncological centers of 4 regions of Kazakhstan, where there were University Clinics.

Distribution of Colorectal Cancer Patients (CRC) by Type of Treatment.

1. Main group - Chemotherapy according to the FOLFOX regimen in combination with sodium nucleonate 100

2. Control group Chemotherapy according to the FOLFOX regimen 100 Study Design The study design included an evaluation of the effectiveness of FOLFOX chemotherapy in combination with sodium nucleinate immunotherapy in 187 patients with metastatic colorectal cancer at stages T3-4 N1-2 M1. Randomization into two groups-main and control-was performed using the envelope method.

The main group included 89 patients with metastatic colorectal cancer (stages T3-4 N1-2 M), receiving four courses of FOLFOX chemotherapy combined with mitochondrial immunotherapy using sodium nucleinate. The medical rehabilitation protocol involved administering sodium nucleinate at 50 mg per day: 25 mg in the morning and 25 mg at lunch before meals, daily for four months.

The control group consisted of 98 patients with metastatic colorectal cancer (stages T3-4 N1-2 M), who received only four courses of FOLFOX chemotherapy. In both groups, general and biochemical blood analyses were conducted monthly.

Additionally, before the start of treatment and one month after the end of treatment, PET-CT scans were performed, levels of tumour markers CEA and CA-19-9 were determined, immunological status CD4/CD8 and mitochondrial activity of neutrophils were assessed, and echocardiography was conducted to determine the left ventricular ejection fraction. A well-being questionnaire (the European Organization for Research and Treatment of Cancer (EORTC) QLQ-CR29) was also administered.

Critical Points

1. Reduction in treatment interruptions due to leukopenia, neutropenia, and infectious complications during chemotherapy for metastatic colorectal cancer (CRC).

2. Increased percentage of tumour process stabilization during palliative chemotherapy for CRC.

Reduction in one-year mortality during palliative treatment of metastatic CRC. Statistical analysis of the study results was performed using the application program package "Statistica 7.0" for Windows (StatSoft, USA). The Mann-Whitney U-criterion was used to compare the studied samples by qualitative indicators.

Conditions

Monitoring, Immunologic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Chemotherapy according to the FOLFOX regimen in combination with sodium nucleonate

Рatients with metastatic colorectal cancer (stages T3-4 N1-2 M), receiving four courses of FOLFOX chemotherapy (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) combined with mitochondrial immunotherapy using sodium nucleinate. The medical rehabilitation protocol involved administering sodium nucleinate at 50 mg per day: 25 mg in the morning and 25 mg at lunch before meals, daily for four months.

Group Type: ACTIVE_COMPARATOR

Adenorine

Intervention Type: DIETARY_SUPPLEMENT

The immunostimulating effect of the drug is associated with its ability to activate the cells of the monocyte-macrophage system, thus increasing the functional activity of all parts of the body, stimulating the repair and regeneration of cells and tissues. It reduces the symptoms of the iflammatory process, stimulates the development of granulations and growth of epithelial tissues, accelerates the process of cleansing and healing of infected wounds. While with healthy people, it can be used as a phylactic drug that improves immunity protection. It was proved that when the drug is used externally, activation of macrophages occurs, thus accelerating wound cleansing process and stimulating reparative processes. In cases when thermal injury to the skin is more than 15-20% of the surface, there is a "stress syndrome" that suppresses the immune system. When exposed to DNA-Na, lymphocyte activation occurs, wound cleansing processes are accelerated.

FOLFOX regimen

Intervention Type: 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

Рatients with metastatic colorectal cancer (stages T3-4 N1-2 M), who received only four courses of FOLFOX chemotherapy (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). In both groups, general and biochemical blood analyses were conducted monthly

Group Type: SHAM_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Placebo

FOLFOX regimen

Intervention Type: 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)

Interventions

Adenorine

The immunostimulating effect of the drug is associated with its ability to activate the cells of the monocyte-macrophage system, thus increasing the functional activity of all parts of the body, stimulating the repair and regeneration of cells and tissues. It reduces the symptoms of the iflammatory process, stimulates the development of granulations and growth of epithelial tissues, accelerates the process of cleansing and healing of infected wounds. While with healthy people, it can be used as a phylactic drug that improves immunity protection. It was proved that when the drug is used externally, activation of macrophages occurs, thus accelerating wound cleansing process and stimulating reparative processes. In cases when thermal injury to the skin is more than 15-20% of the surface, there is a "stress syndrome" that suppresses the immune system. When exposed to DNA-Na, lymphocyte activation occurs, wound cleansing processes are accelerated.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: BIOLOGICAL

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)

Intervention Type: DRUG

Other Intervention Names

natural oligodeoxynucleotide; sodium nucleinate

Eligibility Criteria

Inclusion Criteria

1. Oncological patients with a histologically confirmed diagnosis of "colorectal cancer" and regional metastases at stages T1-4 N1-2 M0, who have provided informed consent to participate in the study.

2. Oncological patients with a histologically confirmed diagnosis of "colorectal cancer" with distant metastases at stages T1-4 N1-2 M1, who have provided informed consent to participate in the study.

Exclusion Criteria

1. Oncological patients with a histologically confirmed diagnosis of "colorectal cancer" and regional metastases at stages T1-4 N1-2 M1, who have active forms of pulmonary tuberculosis, decompensated diabetes, decompensated cardiac, vascular, lung, liver, and renal failure.

2. Oncological patients with a histologically confirmed diagnosis of "colorectal cancer" with regional and distant metastases at stages T1-4 N1-2 M1, who have not provided informed consent to participate in the study.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MIPO Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MIPOClinic

Almaty, , Kazakhstan

Countries

Kazakhstan

Other Identifiers

3

Identifier Type: -

Identifier Source: org_study_id