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

September 26, 2023 updated by: Zhou Fuxiang, Zhongnan Hospital

Clinical Research of 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

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

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Recruiting
        • Zhongnan Hopital of Wuhan University
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / 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.
Other Names:
  • Ascorbic acid
Drug: Metformin
Participants will orally take metformin 4g daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: up to 12 weeks
Defined 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 Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: up to 12 weeks
Defined as time from first dose of treatment until death.
up to 12 weeks
Objective response rate
Time Frame: up to 12 weeks
Overall Response Rate, as determined by the percentage of patients achieving Partial or Complete response per RECIST 1.1.
up to 12 weeks
Disease control rate
Time Frame: up to 12 weeks
Disease 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 life
Time Frame: up to 12 weeks
Examination 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 v3.0
Time Frame: up to 12 weeks
The 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

Collaborators and Investigators

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

Sponsor

Zhongnan Hospital

Investigators

  • Study Chair: Fuxiang Zhou, M.D, Wuhan University

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 Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 20, 2019

First Submitted That Met QC Criteria

July 24, 2019

First Posted (Actual)

July 25, 2019

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZNCM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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