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OncoMatch/Clinical Trials/NCT04516681

Combination of IV Ascorbic Acid and Adebrelimab in Metastatic Colorectal Cancer

Is NCT04516681 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Ascorbic acid and FOLFOX Protocol for colorectal cancer.

Phase 3RecruitingFudan UniversityNCT04516681Data as of May 2026

Treatment: Ascorbic acid · FOLFOX Protocol · AdebrelimabPrevious 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.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Biomarker criteria

Required: SLC2A3 strong positive (strong positive)

IHC confirmed strong positive GLUT3

Excluded: SLC2A3 low or moderate expression

Patients with low or moderate expression of GLUT3 [excluded]

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic therapy for metastatic disease

Exception: adjuvant therapy with fluoropyrimidines +/- oxaliplatin based regimens allowed if stopped 12 months prior to registration on study

Prior treatment for metastatic disease (adjuvant therapy with fluoropyrimidines +/-oxaliplatin based regimens allowed if stopped 12 months prior to registration on study)

Lab requirements

Blood counts

ANC ≥1,500/mm3; Hemoglobin > 8g/dL; platelet ≥ 100,000/mm3

Kidney function

creatinine ≤1.5X ULN; if elevated but ≤1.5X ULN, CrCl > 50 mL/min (Cockroft and Gault)

Liver function

Transaminase (AST/ALT) ≤2.5X ULN and bilirubin ≤1.5X ULN without liver metastasis; AST/ALT ≤5X ULN and bilirubin ≤1.5X ULN with liver metastasis

ANC ≥1,500/mm3; Hemoglobin > 8g/dL; platelet ≥ 100,000/mm3; creatinine ≤1.5X ULN; if elevated but ≤1.5X ULN, CrCl > 50 mL/min (Cockroft and Gault); AST/ALT ≤2.5X ULN and bilirubin ≤1.5X ULN without liver metastasis; AST/ALT ≤5X ULN and bilirubin ≤1.5X ULN with liver metastasis

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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