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Immunosurveillance for Metastatic Colorectal Cancer

NCT06509880 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-07-19

No results posted yet for this study

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.

Conditions

  • Monitoring, Immunologic

Interventions

DIETARY_SUPPLEMENT

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.

BIOLOGICAL

Placebo

Placebo

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
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-07-15
Primary Completion
2024-07-25
Completion
2024-07-31

Countries

  • Kazakhstan

Study Locations

More Related Trials

Entities

Drugs

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