Hepatocellular CancerPhase 2NCT04033107
High Dose Vitamin C Combined With Metformin in the Treatment of Malignant Tumors
A Phase 2 study testing Vitamin C and Metformin in people with Hepatocellular Cancer and Pancreatic Cancer, run by Zhongnan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Cancer, Pancreatic Cancer, Gastric Cancer
- What is being tested?
- Vitamin C and Metformin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hopital of Wuhan University
Wuhan, Hubei, 430071
Fuxiang Zhou, M.D, +86-027-67813155, fuxiang.zhou@whu.edu.cn
About this study
Official title: 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.
- Medical subject headings
- Liver Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDrug
Also called Ascorbic acid
Participants will receive intravenous Vitamin C injection (dose: 1.5g/kg, D1-3, every 2 weeks), treatment termination when the disease progress is confirmed.
MetforminDrug
Participants will orally take metformin 4g daily.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Vitamin C combined with metformin Receives: Drug: Vitamin C; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 weeks
Secondary outcomes (5)
Overall survival
Defined as time from first dose of treatment until death.
Measured: up to 12 weeks
Objective response rate
Overall Response Rate, as determined by the percentage of patients achieving Partial or Complete response per RECIST 1.1.
Measured: up to 12 weeks
Disease control rate
Disease Control Rate: the number of patients with a CR, PR or SD lasting at least 2 months per RECIST 1.1.
Measured: up to 12 weeks
Changes of quality of life
Examination of quality of life by EORTC QLQ-C30 questionnaire every 8 weeks.
Measured: up to 12 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0
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.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start1 Jul 2020
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Fuxiang, Zhongnan Hospital
- Investigators
- Fuxiang Zhou, M.D, Study chair, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033107
- Sponsor's protocol ID
- ZNCM
- Status last verified
- Sep 2023
- First submitted
- 20 Jul 2019
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research of High Dose Vitamin C Combined With Metformin in the Treatment of Malignant Tumors
- ClinicalTrials.gov ID
- NCT04033107
- Acronym / sponsor ID
- ZNCM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Vitamin C, Drug: MetforminVitamin C combined with metformin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin CAlso: Ascorbic acidParticipants will receive intravenous Vitamin C injection (dose: 1.5g/kg, D1-3, every 2 weeks), treatment termination when the disease progress is confirmed. | Drug | Treatment arm |
| MetforminParticipants will orally take metformin 4g daily. | Drug | Treatment arm |
Primary outcome
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.
5 secondary outcomes
Overall survival
Time frame: up to 12 weeks
Objective response rate
Time frame: up to 12 weeks
Disease control rate
Time frame: up to 12 weeks
Changes of quality of life
Time frame: up to 12 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v3.0
Time frame: up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fuxiang Zhou, M.D study chair
Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin C and Metformin in people with Hepatocellular Cancer and Pancreatic Cancer, run by Zhongnan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fuxiang Zhou, M.D (+86-027-67813155, fuxiang.zhou@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.