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

NCT ID: NCT04033107

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment arm

Vitamin C combined with metformin

Group Type: EXPERIMENTAL

Vitamin C

Intervention Type: 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.

Metformin

Intervention Type: DRUG

Participants will orally take metformin 4g daily.

Interventions

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.

Intervention Type: DRUG

Metformin

Participants will orally take metformin 4g daily.

Intervention Type: DRUG

Other Intervention Names

Ascorbic acid

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongnan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhou Fuxiang

Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fuxiang Zhou, M.D

Role: STUDY_CHAIR

Wuhan University

Locations

Zhongnan Hopital of Wuhan University

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fuxiang Zhou, M.D

Role: CONTACT

fuxiang.zhou@whu.edu.cn

+86-027-67813155

Facility Contacts

Fuxiang Zhou, M.D

Role: primary

fuxiang.zhou@whu.edu.cn

+86-027-67813155

Other Identifiers

ZNCM

Identifier Type: -

Identifier Source: org_study_id