Combination of IV Ascorbic Acid and Adebrelimab in Metastatic Colorectal Cancer

Last updated: October 22, 2024
Sponsor: Fudan University
Overall Status: Active - Recruiting

Phase

3

Condition

Colorectal Cancer

Colon Cancer

Rectal Cancer

Treatment

FOLFOXIRI Protocol

Ascorbic acid

FOLFOX Protocol

Clinical Study ID

NCT04516681
Vitamin C-GLUT3-2020
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Age≥18 years, ≤75 years; Histologically proven peritoneal metastatic adenocarcinomaof colorectal cancer, unresectable metastatic disease; IHC confirmed strong positiveGLUT3; measurable disease; Eastern Cooperative Oncology Group (ECOG) performancestatus 0 to 1; Life expectancy of at least 12 weeks; ANC ≥1,500/mm3; Hemoglobin > 8g/dL; platelet ≥ 100,000/mm3; Laboratory at baseline evaluation for inclusion inthe study: creatinine ≤1.5X upper limit [if the creatinine is elevated, but ≤1.5Xthe ULN, a 24 hour creatinine clearance will be obtained, Creatinine clearance > 50mL/min (calculated according to Cockroft and Gault)]; Transaminase (AST/ALT) ≤2.5Xupper limit of normal and bilirubin levels ≤1.5X upper limit of normal without livermetastasis; Transaminase (AST/ALT) ≤5X upper limit of normal and bilirubin levels ≤1.5X upper limit of normal with liver metastasis; Written informed consent

Exclusion

Exclusion Criteria:

  • Prior treatment for metastatic disease (adjuvant therapy with fluoropyrimidines +/-oxaliplatin based regimens allowed if stopped 12 months prior to registration onstudy); Surgery (excluding diagnostic biopsy) or irradiation within 3 weeks prior tostudy entry; Administration of any investigational drug or agent/procedure, i.e.participation in another trial within 4 weeks before beginning treatment; Concurrentchronic systemic immune therapy, chemotherapy, radiation therapy (palliativeradiation therapy allowed) or hormone therapy not indicated in the study protocol;Brain metastasis (known or suspected); Pregnant or lactating women; Otheruncontrolled concomitant illness, including serious uncontrolled intercurrentinfection; Known allergy or any other adverse reaction to any of the drugs or to anyrelated compound; Previous (within 5 years) or concurrent malignancies at othersites with the exception of surgically cured or adequately treated carcinoma in-situof the cervix and basal cell carcinoma of the skin; Patients with low or moderateexpression of GLUT3.

Study Design

Total Participants: 400
Treatment Group(s): 4
Primary Treatment: FOLFOXIRI Protocol
Phase: 3
Study Start date:
December 01, 2024
Estimated Completion Date:
December 01, 2025

Connect with a study center

  • Fudan university shanghai cancer center

    Shanhai, Shanghai 200032
    China

    Active - Recruiting

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