RecruitingPhase 3NCT04516681

Combination of IV Ascorbic Acid and Adebrelimab in Metastatic Colorectal Cancer

Vitamin C Intravenously With Chemotherapy and Adebrelimab in Metastatic Colorectal Cancer With High Expresison Level of GLUT3

Sponsor

Fudan University

Enrollment

400 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer Vitamin C GLUT3

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining high-dose intravenous vitamin C with an immunotherapy drug (adebrelimab) can improve outcomes in people with colorectal cancer that has spread to the lining of the abdomen (peritoneal metastases). **You may be eligible if...** - You are between 18 and 75 years old - You have colorectal cancer that has spread and cannot be removed by surgery - Your tumor tests positive for a specific protein (GLUT3) on pathology - You are in good physical condition (ECOG 0-1) - You have tried and failed standard treatments **You may NOT be eligible if...** - Your cancer does not express GLUT3 - You have significant kidney disease or other organ problems - You have uncontrolled infections or autoimmune conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAscorbic acid

1.5g/kg/day, D1-3, every 2 weeks

DRUGFOLFOX Protocol

Oxaliplatin 130 mg/m² d1 concurrent with Leucovorin 400 mg/m², followed by Oxaliplatin 85 mg/m² d1 followed by Bolus 5FU 400 mg/m² , followed by Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks with or without bevacizumab 5mg/kg, every 2 weeks

DRUGAdebrelimab

20mg/Kg intravenously every 3 weeks

Locations(1)

Fudan university shanghai cancer center

Shanhai, Shanghai Municipality, China

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NCT04516681

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