drugset / Trial / NCT06509880

Immunosurveillance for Metastatic Colorectal Cancer

NCT06509880

Phase 2/3 Completed 187 enrolled MIPO Clinic
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Adenorine Oligonucleotide (other) 50 mg Oral
Comparator Leucovorin Small molecule 400 mg/m2 Intravenous
Comparator Levoleucovorin Unknown 200 mg/m2 Intravenous
Comparator Oxaliplatin Small molecule 100 mg/m2 Intravenous
Comparator fluorouracil Small molecule 400 mg/m2 Intravenous
Comparator fluorouracil Small molecule 2400 mg/m2 Intravenous
Comparator fluorouracil Small molecule 3000 mg/m2 Intravenous

Indications

No indication recorded.