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Clinical Trial Record

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High Dose Vitamin C Combined With Metformin in the Treatment of Malignant Tumors

2020-07-01

2024-12

2024-12

30

Study Overview

High Dose Vitamin C Combined With Metformin in the Treatment of Malignant Tumors

This is an open, prospective, single-arm, multi-cohort clinical study to evaluate the efficacy and safety of high-dose vitamin C combined with metformin in the treatment of malignant tumors.

N/A

  • Hepatocellular Cancer
  • Pancreatic Cancer
  • Gastric Cancer
  • Colorectal Cancer
  • DRUG: Vitamin C
  • DRUG: Metformin
  • ZNCM

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2019-07-20  

N/A  

2023-09-26  

2019-07-24  

N/A  

2023-09-28  

2019-07-25  

N/A  

2023-09  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Treatment arm

Vitamin C combined with metformin

DRUG: Vitamin C

  • Participants will receive intravenous Vitamin C injection (dose: 1.5g/kg, D1-3, every 2 weeks), treatment termination when the disease progress is confirmed.

DRUG: Metformin

  • Participants will orally take metformin 4g daily.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Progression-free survivalDefined as time from first dose of treatment to death from any cause, or even radiological detection/or clinical of disease progression.up to 12 weeks
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Overall survivalDefined as time from first dose of treatment until death.up to 12 weeks
Objective response rateOverall Response Rate, as determined by the percentage of patients achieving Partial or Complete response per RECIST 1.1.up to 12 weeks
Disease control rateDisease Control Rate: the number of patients with a CR, PR or SD lasting at least 2 months per RECIST 1.1.up to 12 weeks
Changes of quality of lifeExamination of quality of life by EORTC QLQ-C30 questionnaire every 8 weeks.up to 12 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0The number of grade 1-4 and grade 5 (fatal) NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) events during treatment. All patients will be evaluable for toxicity from the time of their first treatment.up to 12 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Fuxiang Zhou, M.D

Phone Number: +86-027-67813155

Email: fuxiang.zhou@whu.edu.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. 18 years to 75 years. 2. Had a disease status that was measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version1.1)： Cohort A: patients with advanced hepatocellular carcinoma who had failed previous standard first-line therapy and could not tolerate or reject existing therapies.
    Cohort B: patients with advanced pancreatic cancer who had previously failed standard first-line therapy, could not tolerate or reject existing therapies.
    Cohort C: patients with advanced gastric cancer who had failed previous standard second-line or above treatment, who could not tolerate or reject existing therapies.
    Cohort D: patients with advanced colorectal cancer who had failed previous standard second-line or above treatment, who could not tolerate or reject existing therapies. 3. Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥80g/L, platelets ≥ 80×10^9/L, neutrophils ≥ 1.5×10^9/L, total bilirubin within 1.5×the upper limit of normal(ULN), ALT and AST≤2.5×the ULN (If liver metastases, serum transaminase≤5×the ULN), serum creatine ≤ 1.5 x ULN, creatinine clearance rate > 50ml/min). 4. At least 4 weeks after the last anti-tumor treatment (surgery, chemotherapy, radiotherapy, biotherapy or endocrine therapy) before enrollment. 5. Had a life expectancy of at least 3 months. 6. Had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2. 7. Signed informed consent.
    Exclusion Criteria:
    1. In the past or at the same time with other malignant tumors (already cure period of IB or cervical, lower levels of noninvasive basal cell or squamous cell cancer, obtain complete remission (CR) > 10 years of breast cancer, obtain complete remission (CR) > 10 years of malignant melanoma, obtain complete remission (CR) > 5 years except of other malignant tumors). 2. Pregnant or lactating female patients. 3. Those who have applied excessive dose of vitamin C or (and) metformin in recent 1 month. 4. Patients with glucose-6-phosphate dehydrogenase deficiency. 5. Patients with hydronephrosis. 6. Had a history of clinically significant or uncontrolled heart disease, including but not limited to: (1)Myocardial infarction. (2)Angina.(3)Congestive heart failure above grade 2 of the New York heart association (NYHA).(4)Ventricular arrhythmias requiring continuous treatment.(5)Supraventricular arrhythmias, including uncontrolled atrial fibrillation. 7. The patients had mental disorders, and the researchers believed that the patients could not fully or fully understand the possible complications in this study. 8. Have a history of immunodeficiency, including: HIV positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation. 9. Those who cannot tolerate or may be allergic to the drugs used in this study. 10. Participated in clinical trials of other drugs within the past 1 month. 11. Other factors considered unsuitable for the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • STUDY_CHAIR: Fuxiang Zhou, M.D, Wuhan University

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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