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

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Trial Information

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

2 year

Safety Issue:


Principal Investigator

shen lin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

peking university, school of oncology, department of GI oncology


China: Food and Drug Administration

Study ID:




Start Date:

May 2009

Completion Date:

June 2012

Related Keywords:

  • Advanced Esophageal Carcinoma
  • Carcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms