drugset / Trial / NCT04516681

Combination of IV Ascorbic Acid and Adebrelimab in Metastatic Colorectal Cancer

NCT04516681

Phase 3 Recruiting 400 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

Previous preclinical study has shown that high levels of ascorbic acid (AA) possesses the ability to kill human colorectal cancer cells and high expression of GLUT3 will augment the efficacy of AA. To date, no previous studies have investigated the combination of therapeutic role of AA and PD-L1 antibody in metastatic colorectal cancer with high expression of GLUT3. This protocol is a randomized controlled study of AA infusions combined with Adebrelimab and FOLFOX +/- bevacizumab versus treatment with FOLFOX +/- bevacizumab alone in metastatic colorectal cancer patients with high expression of GLUT3.

Timeline

Start
2024-12-01
Primary completion
2025-12-01
Completion
2025-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Adebrelimab Monoclonal antibody 20 mg/kg Intravenous
Subject Vitamin C Other / unclassified 1.5 g/kg Intravenous
Background Bevacizumab Monoclonal antibody 5 mg/kg
Background Leucovorin Small molecule 400 mg/m2
Background Oxaliplatin Small molecule 85 mg/m2
Background Oxaliplatin Small molecule 130 mg/m2
Background fluorouracil Small molecule 400 mg/m2
Background fluorouracil Small molecule 2400 mg/m2

Indications