Clinical trial NCT01232374: Nimotuzumab in Combination With Chemoradiation for Local Advanced Esophageal Squamous Cell Carcinoma
Official title: A Clinical Study of Nimotuzumab in Combination With Concurrent Chemotherapy and Radiation for Patients With Local Advanced Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Squamous Cell Carcinoma
Keywords: Nimotuzumab
local advanced esophageal squamous cell carcinoma
chemo-irradiation
Lead sponsor: Biotech Pharmaceutical Co., Ltd.
Sponsor class: OTHER
First posted: 2010-11-02
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 been approved to treat squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries. The clinical phase I study of the combination of Nimotuzumab administered concurrently with chemo-irradiation in patients with local advanced esophageal squamous cell carcinoma (LAFSCC) has shown the safety and the potential efficacy of Nimotuzumab. 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 further investigate its side-effect and toxicity.

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 further investigate its side-effect and toxicity.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Response rate of Nimotuzumab combined with chemo-irradiation
timeFrame: 2 months after radiotherapy
measure: 1-yr overall survivals
timeFrame: 1 year
measure: 2-yr overall survival
timeFrame: 2 year
measure: 3-yr overall survival
timeFrame: 3 years
Secondary outcomes:
measure: Local progression-free survival
timeFrame: 3 years
measure: Disease progression-free survival
timeFrame: 3 years
measure: Distant metastasis rate
timeFrame: 3 years
measure: Number and grade of Participants with Adverse Events
timeFrame: 6 months
measure: Quality of life
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences Cancer Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Provincial Tumor Hospital
state: Fujian
city: Guangzhou
country: China
facility: Cancer Center of Sun Yat-sen
state: Guangdong
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Huazhong University of Science and Technology, Union Hospital, Tongji Medical College
state: Hubei
city: Nanjing
country: China
facility: Cancer Hospital of Jiangsu Province
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University,Suzhou First People's Hospital
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
city: Changchun
country: China
facility: The first bethune hospital of Jilin university
state: Jilin
city: Qingdao
country: China
facility: Affiliated Hospital of Qingdao University Medical College
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First People's Hospital
state: Shanghai
city: Xian
country: China
facility: Fourth Military Medical University Xijing Hospital
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: