Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
NCT ID:
NCT03833466
Eligibility Criteria:
Inclusion Criteria:
* Having signed informed consent.
* Age 18 to 70 years old
* Histologically confirmed esophageal squamous carcinoma
* Computed tomography (CT) or magnetic resonance imaging (MRI) confirmed advanced ESCC which need neoadjuvant chemotherapy before surgical resection.
* Measurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 21 days before enrollment)
* Life expectancy of ≥3 month
* Eastern Cooperative Oncology Group (ECOG) 0-1
* Body Mass Index (BMI) ≥18.5kg/m2
* WBC\>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet\>100,000/mm3, Hb\>9g/dl，Bilirubin level \< 1.5 times ULN，Serum creatinine \<1.5 times ULN，ALT and AST\<2.5 times ULN ，AKP \< 2.5 times ULN ，(≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
* No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever\>38℃.
* Good compliance
Exclusion Criteria:
* Have used metformin or biguanide in the past
* Contraindications of metformin
* Unable to take metformin orally because of esophageal stenosis
* Currently receiving other effective regimens
* Previous anticipate other clinical trial within 4 weeks before entering this study
* No measurable lesions, eg. pleural fluid and ascites\\
* Only with other previous malignancy within 5 year, except non-melanoma skin cancer and cervical carcinoma in situ
* Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months only Brain or bone metastasis
* Mentally abnormal or disable cognition,including central nervous system (CNS) metastasis
* HIV infection, active hepatitis B or hepatitis C
* Unstable systemic diseases such as poorly controlled diabetes
* Interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease showed in X-ray/CT
* Known hypersensitivity to study drugs
* Pregnancy or lactation period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03833466
Study Brief:
Protocol Section:
NCT03833466