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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Zhongnan Hopital of Wuhan University
Wuhan, Hubei, China
RECRUITINGProgression-free survival
Defined as time from first dose of treatment to death from any cause, or even radiological detection/or clinical of disease progression.
Time frame: up to 12 weeks
Overall survival
Defined as time from first dose of treatment until death.
Time frame: 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.
Time frame: 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.
Time frame: up to 12 weeks
Changes of quality of life
Examination of quality of life by EORTC QLQ-C30 questionnaire every 8 weeks.
Time frame: 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.
Time frame: up to 12 weeks
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