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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | Vitamin C combined with metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Defined as time from first dose of treatment until death. | 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. |
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Inclusion Criteria:
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).
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fuxiang Zhou, M.D | Contact | +86-027-67813155 | fuxiang.zhou@whu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Fuxiang Zhou, M.D | Wuhan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hopital of Wuhan University | Recruiting | Wuhan | Hubei | 430071 | China |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D013274 | Stomach Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Metformin | Drug | Participants will orally take metformin 4g daily. |
|
| 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. | up to 12 weeks |
| Changes of quality of life | 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 | 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 |
| D008107 |
| Liver Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |