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:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT02023593
Eligibility Criteria:
Inclusion Criteria:
* Patients have provided a signed Informed Consent Form
* Karnofsky score ≥70
* Age: 18-75 years old
* Histologically confirmed diagnosis of advanced esophageal carcinoma
* Patients have Received and progressed on first-line treatment, and not received CPT-11 or Fluoropyrimidine based palliative chemotherapy
* Measurable disease in at least 1 diameter by CT scan or MRI as per RECIST 1.1 criteria
* Life expectancy ≥ 3 months
* Patient has adequate bone marrow and organ function
* Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
* Platelets ≥ 75 x 109/L
* Hemoglobin ≥ 9.0 g/dL
* Patient has adequate liver function
* AST and ALT not more than 2.5 times ULN (not more than 5.0 times ULN if there is liver metastasis)
* Serum bilirubin ≤ 2 x ULN
* Creatinine ≤ 1.5 times ULN
* Good compliance
Exclusion Criteria:
* Pregnant or lactating women
* Brain metastasis or only with bone metastasis.
* Patients with severe infection or active peptic ulcer which need treatment
* Severe systemic disease out of control such as unstable or uncompensated respiratory, cardiac, liver, renal diseases
* Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of non-melanoma skin cancer or cervical carcinoma in situ
* Psychiatric illness that would prevent the patient from giving informed consent
* Patient is concurrently using other approved or investigational antineoplastic agent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02023593
Study Brief:
Protocol Section:
NCT02023593