Using high-dose vitamin C with metformin to treat certain cancers

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

This study is testing whether high-dose vitamin C combined with metformin can help people with advanced cancers like liver, pancreatic, stomach, and colorectal cancers who haven't had success with other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Zhongnan Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT04033107 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of high-dose vitamin C combined with metformin for patients with advanced malignant tumors, including hepatocellular, pancreatic, gastric, and colorectal cancers. It is an open, prospective, single-arm, multi-cohort study, meaning all participants will receive the same treatment without a control group. The study aims to enroll patients who have previously failed standard therapies and cannot tolerate or reject existing treatments. The trial will assess measurable disease status based on established criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with advanced hepatocellular, pancreatic, gastric, or colorectal cancers who have failed prior therapies.

Not a fit: Patients with early-stage cancers or those who have not yet undergone standard treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers who have limited treatment alternatives.

How similar studies have performed: While the combination of vitamin C and metformin is being explored, this specific approach in treating these advanced cancers is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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.

Where this trial is running

Wuhan, Hubei

• Zhongnan Hopital of Wuhan University — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Fuxiang Zhou, M.D

Conditions Hepatocellular Cancer; Pancreatic Cancer; Gastric Cancer; Colorectal Cancer