Actively Recruiting
Vitamin C Intravenously With Chemotherapy and Adebrelimab in Metastatic Colorectal Cancer With High Expression of GLUT3
Led by Fudan University · Updated on 2024-10-24
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new treatment approach for patients with metastatic colorectal cancer who have high levels of GLUT3 protein. This study compares the combination of intravenous ascorbic acid (vitamin C) infusions with the PD-L1 antibody Adebrelimab and chemotherapy (FOLFOX, with or without bevacizumab) against chemotherapy alone. Previous lab studies showed that high doses of ascorbic acid may kill colorectal cancer cells, especially when GLUT3 expression is high, but this combination has not been tested in patients before. Participants in the experimental group will receive ascorbic acid at a dose of 1.5 grams per kilogram per day for three days every two weeks, along with Adebrelimab infusions every three weeks and chemotherapy cycles every two weeks. The comparison group will receive the standard FOLFOX chemotherapy regimen, with or without bevacizumab, without ascorbic acid or Adebrelimab. The study is randomized and open-label, meaning participants are assigned by chance to one of these two treatment groups. During the study, patients will be closely monitored through regular medical assessments to evaluate tumor response by objective response rate over up to five years. Researchers will also track progression-free survival and overall survival as secondary outcomes. Laboratory tests will assess blood counts and organ functions to ensure safety. The total study duration per participant will depend on treatment response and follow-up for up to five years to gather long-term data on treatment effects and safety.
CONDITIONS
Brief 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 colorectal adenocarcinoma
- Unresectable metastatic disease
- Strong positive GLUT3 protein 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
- Baseline laboratory values within specified limits for creatinine, liver enzymes, and bilirubin
- Written informed consent provided
You will not qualify if you...
- Prior treatment for metastatic disease (except adjuvant fluoropyrimidines +/- oxaliplatin if stopped 12 months before study entry)
- Surgery (excluding diagnostic biopsy) or radiation therapy within 3 weeks before study entry
- Participation in another investigational drug trial within 4 weeks before treatment
- Concurrent immune therapy, chemotherapy, radiation therapy (except palliative), or hormone therapy not specified in the protocol
- Known or suspected brain metastases
- Pregnant or breastfeeding women
- Serious uncontrolled illnesses, including infections
- Allergies or adverse reactions to study drugs or related compounds
- Previous or concurrent cancers at other sites within 5 years, except certain treated skin or cervical cancers
- Low or moderate GLUT3 expression in tumor tissue
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 2-week cycles with Ascorbic Acid given on Days 1 to 3, and Adebrelimab every 3 weeks, continuing as per study protocol.
Participants receive chemotherapy with or without intravenous Ascorbic Acid and Adebrelimab according to their assigned group.
Visits every 2 weeks for chemotherapy and Ascorbic Acid; Adebrelimab given every 3 weeks
Trial Site Locations
Total: 1 location
1
Fudan university shanghai cancer center
Shanhai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
G
Guoxiang Cai
R
Renjie Wang
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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