Actively Recruiting
Combination of IV Ascorbic Acid and Adebrelimab in Metastatic Colorectal Cancer
Led by Fudan University · Updated on 2024-10-24
400
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Combination of IV Ascorbic Acid and Adebrelimab in Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Histologically confirmed peritoneal metastatic adenocarcinoma of colorectal cancer that is unresectable
- Strong positive GLUT3 expression confirmed by immunohistochemistry
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Life expectancy of at least 12 weeks
- Absolute neutrophil count (ANC) of at least 1,500/mm3
- Hemoglobin level greater than 8 g/dL
- Platelet count of at least 100,000/mm3
- Creatinine level at or below 1.5 times the upper limit of normal or creatinine clearance over 50 mL/min if creatinine elevated
- Transaminase (AST/ALT) levels no more than 2.5 times upper limit of normal and bilirubin levels no more than 1.5 times upper limit of normal without liver metastasis
- Transaminase (AST/ALT) levels no more than 5 times upper limit of normal and bilirubin levels no more than 1.5 times upper limit of normal with liver metastasis
- Written informed consent provided
You will not qualify if you...
- Prior treatment for metastatic disease (except adjuvant therapy with fluoropyrimidines and/or oxaliplatin stopped at least 12 months before enrollment)
- Surgery (other than diagnostic biopsy) or radiation therapy within 3 weeks before study entry
- Participation in another investigational drug or procedure trial within 4 weeks before starting treatment
- Concurrent chronic systemic immune therapy, chemotherapy, radiation therapy (except palliative radiation), or hormone therapy not specified in the study
- Known or suspected brain metastases
- Pregnant or breastfeeding women
- Uncontrolled illnesses including serious infections
- Known allergy or adverse reaction to study drugs or related compounds
- Previous or concurrent malignancies other than adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin
- Low or moderate GLUT3 expression
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan university shanghai cancer center
Shanhai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
G
Guoxiang Cai
CONTACT
R
Renjie Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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