Actively Recruiting
Phase I Study of High-Dose Vitamin C Infusion Combined With Standard Therapy in Advanced Malignant Solid Tumors
Led by Zhongnan Hospital · Updated on 2025-08-13
18
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of high-dose vitamin C (HDVC) given intravenously in patients with advanced malignant solid tumors who are also receiving standard systemic anti-tumor treatments. Vitamin C is essential for the body and may have anti-tumor effects, especially when given at high doses intravenously. Past research suggests that maintaining higher blood concentrations of vitamin C for longer periods might improve its potential anti-cancer effects, which this study aims to explore further with different dosing schedules. Participants receive HDVC intravenously in three different regimens: 0.5 grams per kilogram once daily, 0.5 grams per kilogram twice daily, or 0.75 grams per kilogram twice daily. Each regimen is given continuously for 5 to 7 days during the first cycle of their standard systemic cancer therapy. Researchers will measure vitamin C blood levels daily to understand how different dosing affects vitamin C concentration in the body. During the study, participants will be monitored closely with daily blood tests to track vitamin C levels and assess how the vitamin behaves in the body over time. The main outcome is to study the pharmacokinetics of these dosing regimens from baseline through day 7. The study aims to find the best way to combine HDVC with standard cancer treatments to optimize potential benefits. The total participation period covers the first treatment cycle and vitamin C administration days, with ongoing evaluation of safety and effects.
CONDITIONS
Brief Title
High - Dose Vitamin C Infusion Regimen Based on Pharmacokinetic Characteristics for Patients With Advanced Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years, any gender
- Voluntary participation with signed informed consent and good compliance
- Histologically or cytologically confirmed advanced or metastatic malignant solid tumor
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- At least one measurable lesion according to RECIST 1.1
- Adequate bone marrow, liver, kidney, and heart function within 7 days before enrollment
- No history of calcium oxalate kidney stones
- Expected survival of at least 12 weeks
- Negative catalase result on pathological immunohistochemistry
- Currently undergoing systemic anti-tumor treatment with disease progression; may continue or change chemotherapy regimen without interruption
You will not qualify if you...
- No pathological diagnosis of malignant solid tumor
- Current or history of central nervous system (brain) metastases
- Severe gastrointestinal diseases, including active bleeding
- Severe or uncontrolled infections, heart, or nervous system diseases
- Major surgery within 4 weeks or local radiotherapy within 7 days before study drug administration
- Dementia or severe mental status changes preventing informed consent
- Women of childbearing potential not using contraception or without pregnancy test within 7 days after first chemotherapy
- Poorly controlled diabetes with fasting blood glucose over 10 mmol/L
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency or hereditary spherocytosis
- Active pulmonary tuberculosis, recent anti-tuberculosis treatment, positive HIV antibodies, or syphilis infection
- Active viral hepatitis not controlled as per study requirements
- Any abnormal labs or medical conditions deemed unfit by investigator
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.
1 visit (in-person)
Duration - 7 days
Participants receive high-dose vitamin C infusions intravenously once or twice daily based on assigned dose arm combined with their standard anti-tumor therapy.
Daily visits for 7 days
Trial Site Locations
Total: 1 location
1
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071
Actively Recruiting
Research Team
L
Lei Yang, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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