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 @ 4:28 AM
Ignite Modification Date:
2025-12-25 @ 4:28 AM
NCT ID:
NCT01044420
Eligibility Criteria:
Inclusion Criteria:
* Having signed informed consent
* Age 18 to 70 years old
* Histologically confirmed esophageal squamous carcinoma,failed to 1st line treatment of paclitaxel/cisplatin
* Unresectable recurrent or metastatic disease
* Measurable disease according to the RECIST 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 15 days before enrollment)
* Karnofsky performance status ≥70
* Life expectancy of ≥3 month
* No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
* ALT and AST\<2.5 times ULN (≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
* Serum AKP \< 2.5 times ULN (within 7 days before enrollment)
* Serum creatinine \<1.0 times ULN (within 7 days before enrollment)
* Bilirubin level \< 1.0 times ULN (within 7 days before enrollment)
* WBC\>4,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl(within 7 days before enrollment)
* No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever\>38℃；
* Good compliance
Exclusion Criteria:
* More than 1 Previous systemic therapy for metastatic esophageal squamous carcinoma
* Known hypersensitivity to irinotecan
* Only with Brain or bone metastasis
* Tumor with length≥10cm, liver metastasis covers more than 50% of liver,or lung metastasis covers more than 25% of lung
* No measurable lesions, eg. pleural fluid and ascites
* Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
* Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months or
* Pregnancy or lactation period
* Other previous malignancy within 5 year, except non-melanoma skin cancer
* Chronic diarrhea
* Mentally abnormal or disable cognition,including CNS metastasis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01044420
Study Brief:
Protocol Section:
NCT01044420