Status:
UNKNOWN
mFOLFIRI Combine With Nimotuzumab Second Line Chemotherapy for Squamous-cell Carcinoma of the Esophagus
Lead Sponsor:
Peking University
Conditions:
Advanced Esophageal Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
There are few studies about 2nd line treatment in advanced esophageal carcinoma (AEC), some showed that irinotecan may be effective. The investigators previous study has shown the efficacy and safety ...
Eligibility Criteria
Inclusion
- Histologically confirmed esophageal squamous carcinoma,failed to 1st line treatment of paclitaxel/cisplatin
- Age 18 to 75 years old
- 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)
- Life expectancy of ≥3 month
- Karnofsky performance status ≥80
- WBC\>3,500/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl，Bilirubin level \< 1.0 times ULN，Serum creatinine \<1.0 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℃；
- Normal ECG/cardiac function
- Good compliance
- Having signed informed consent
Exclusion
- More than 1 Previous systemic therapy for metastatic esophageal squamous carcinoma
- Known hypersensitivity to study drugs
- 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
- Only with Other previous malignancy within 5 year, except non-melanoma skin cancer
- Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months only Brain or bone metastasis
- Chronic diarrhea
- Mentally abnormal or disable cognition,including CNS metastasis
- Pregnancy or lactation period
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01486992
Start Date
November 1 2011
End Date
November 1 2012
Last Update
January 12 2012
Active Locations (1)
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1
Zhang Xiaodong
Beijing, Beijing Municipality, China, 100142