Status:
UNKNOWN
Nimotuzumab in Combination With Chemoradiation for Local Advanced Esophageal Squamous Cell Carcinoma
Lead Sponsor:
Biotech Pharmaceutical Co., Ltd.
Conditions:
Squamous Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Nimotuzumab is a humanized monoclonal antibody against epidermal growth factor receptor (EGFR). Clinical trials are ongoing globally to evaluate Nimotuzumab in different indications. Nimotuzumab has b...
Detailed Description
The concurrent trial is a clinical phase II trial designed to assess the efficacy of the combination of Nimotuzumab administered concurrently with chemo-radiotherapy in patients with LAFSCC, and to fu...
Eligibility Criteria
Inclusion
- Joined the study voluntarily and signed informed consent form;
- Age 18-75
- Both genders
- Esophageal squamous cell carcinoma confirmed by pathology
- Local advanced esophageal squamous cell carcinoma (T2N0M0-TxNxM1a, AJCC 2002)
- No radiotherapy, chemotherapy or other treatments prior to enrollment
- PS ECOG 0-2
- Life expectancy of more than 3 months
- Target lesions measurable
- Hemoglobin（Hb）≥9 g/dL
- WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L
- platelet count (Pt) ≥100x 109/L
- Hepatic function: ALAT and ASAT \< 2.5 x ULN, TBIL\<1.5 x ULN
- Renal function: creatinine \< 1.5 x ULN
- No immuno-deficiency
- Use of an effective contraceptive for adults to prevent pregnancy.
Exclusion
- Complete esophageal obstruction
- Deep esophageal ulcer
- Esophageal perforation
- Haematemesis
- After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy
- Esophageal stent or tracheal stent placed
- Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years
- Participation in other interventional clinical trials within 30 days
- Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
- Drug addiction
- Alcoholism or AIDS
- Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
- History of serious allergic or allergy
- Patients who are not suitable to participate in the trial according to researchers.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2016
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT01232374
Start Date
September 1 2010
End Date
January 1 2016
Last Update
August 20 2015
Active Locations (17)
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1
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing Municipality, China, 266000
2
Fujian Provincial Tumor Hospital
Fuzhou, Fujian, China, 350000
3
Cancer Center of Sun Yat-sen
Guangzhou, Guangdong, China, 510000
4
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052