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

NCT04033107 | Unknown Phase 2

• 1 other identifier: ZNCM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Cancer; Pancreatic Cancer; Gastric Cancer; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  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 Outcomes (5)

• Overall survival

  up to 12 weeks

• Objective response rate

  up to 12 weeks

• Disease control rate

  up to 12 weeks

• Changes of quality of life

  up to 12 weeks

• Number of participants with treatment-related adverse events as assessed by CTCAE v3.0

  up to 12 weeks

Study Arms (1)

Treatment arm

EXPERIMENTAL

Vitamin C combined with metformin

Drug: Vitamin C; Drug: Metformin

Interventions

Vitamin C DRUG

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

Also known as: Ascorbic acid

Treatment arm

Metformin DRUG

Participants will orally take metformin 4g daily.

Treatment arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years to 75 years.
• 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.
• 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).
• At least 4 weeks after the last anti-tumor treatment (surgery, chemotherapy, radiotherapy, biotherapy or endocrine therapy) before enrollment.
• Had a life expectancy of at least 3 months.
• Had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2.
• Signed informed consent.

You may not qualify if:

• 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).
• Pregnant or lactating female patients.
• Those who have applied excessive dose of vitamin C or (and) metformin in recent 1 month.
• Patients with glucose-6-phosphate dehydrogenase deficiency.
• Patients with hydronephrosis.
• 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.
• The patients had mental disorders, and the researchers believed that the patients could not fully or fully understand the possible complications in this study.
• Have a history of immunodeficiency, including: HIV positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
• Those who cannot tolerate or may be allergic to the drugs used in this study.
• Participated in clinical trials of other drugs within the past 1 month.
• Other factors considered unsuitable for the study.

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hopital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms; Pancreatic Neoplasms; Stomach Neoplasms; Colorectal Neoplasms

Interventions

Ascorbic Acid; Metformin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Biguanides; Guanidines; Amidines

Study Officials

• Fuxiang Zhou, M.D

  Wuhan University

  STUDY CHAIR

Central Study Contacts

Fuxiang Zhou, M.D

CONTACT

+86-027-67813155; fuxiang.zhou@whu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: July 20, 2019
• First Posted: July 25, 2019
• Study Start: July 1, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

CN (1)