This is an open-label phase II trial investigating the effect of metformin in combined with cisplatin plus paclitaxel as neoadjuvant therapy with advanced esophageal squamous cell carcinoma.
In this prospective phase II study, eligible patients are received cisplatin plus paclitaxel for 2-4 cycles combined with metformin orally. The investigators aim to compare the tumor metabolic pathway and tumor microenvironment of pre-chemotherapy endoscopic biopsy samples and post-chemotherapy surgical resection samples.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Drug: Metformin Metformin is orally administered as 500mg bid for 7 days and escaladed to 500mg tid if adverse events are tolerated. Drug: Cisplatin Cisplatin is given at 75mg/m2 intravenously on day 1 of each 21 day cycle. Drug: Paclitaxel Paclitaxel is given at 175mg/m2 intravenously on day 1 of each 21 day cycle.
Peking Universtiy Cancer Hospital
Beijing, Beijing Municipality, China
Tumor metabolic pathway
To compare the changes of tumor metabolic pathway of pre-chemotherapy endoscopic biopsy samples and post-chemotherapy surgical resection samples
Time frame: Through study completion, an average of 1 year
Tumor microenvironment
To compare the changes of tumor microenvironment of pre-chemotherapy endoscopic biopsy samples and post-chemotherapy surgical resection samples
Time frame: Through study completion, an average of 1 year
Rate of pathologic complete response(pCR)
Rate of pathologic complete response
Time frame: Through study completion, an average of 1 year
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