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Phase 2
18 Years
75 Years
Open (Enrolling)
Advanced Esophageal Carcinoma

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Trial Information

Inclusion Criteria:

- 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 Criteria:

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

2 years

Safety Issue:



China: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

November 2012

Related Keywords:

  • Advanced Esophageal Carcinoma
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Esophageal Neoplasms