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Nimotuzumab Plus Paclitaxel and Cisplatin as 1st Line Treatment for Esophageal Squamous Cell Cancer : a Single Center Prospective Clinical Trial

Phase 2
18 Years
75 Years
Open (Enrolling)
Esophageal Squamous Cell Cancer

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Trial Information

Nimotuzumab Plus Paclitaxel and Cisplatin as 1st Line Treatment for Esophageal Squamous Cell Cancer : a Single Center Prospective Clinical Trial

Inclusion Criteria:

- Having signed informed consent

- Age 18 to 75 years old

- Histologically confirmed esophageal squamous carcinoma, Unresectable recurrent or
metastatic disease,no prior palliative chemotherapy; No prior radiotherapy except
radiotherapy at non-target lesion of the study more than 3 months,recurrence from
last adjuvant chemotherapy or adjuvant radiotherapy should be longer than 6 months;
no prior treatment of paclitaxel as adjuvant chemotherapy, total dose of cisplatin is
less than 300mg/m2 if used in adjuvant chemotherapy

- Sex is not limited

- 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 ≥80

- Life expectancy of ≥ 3 month

- WBC > 4,000/mm3, absolute neutrophil count ≥2000/mm3, platelet > 100,000/mm3, Hb >
10g/dl(within 14 days before enrollment),ALT and AST < 2.5 times ULN (≤5 times ULN in
patients with liver metastases),Bilirubin level < 1.0 times ULN,Serum AKP < 2.5 times
ULN,Serum creatinine < 1.0 times ULN

- No sever complication, such as active gastrointestinal bleeding, perforation,
jaundice, obstruction, non-cancerous fever > 38℃;

- Normal ECG and heart function

- Fertile patients must use effective contraception

- Good compliance

Exclusion Criteria:

- Previous treatment of palliative chemotherapy or recurrence less than 6 months from
time of last adjuvant chemo-/radiotherapy

- Known hypersensitivity to Nimotuzumab,Paclitaxel,Cisplatin

- 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

- Suffer from severe heart disease or disease with other important organs

- Chronic diarrhea or renal dysfunction

- 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:

Objective response rate

Outcome Description:

CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation

Outcome Time Frame:

6 weeks

Safety Issue:



China: Food and Drug Administration

Study ID:




Start Date:

March 2011

Completion Date:

Related Keywords:

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