Nimotuzumab in Combination With Chemoradiation for Local Advanced Esophageal Squamous Cell Carcinoma

Squamous Cell Carcinoma Clinical Trial

Official title:

A Clinical Study of Nimotuzumab in Combination With Concurrent Chemotherapy and Radiation for Patients With Local Advanced Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01232374
• Other study ID #: BT-ESO-1001
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 12, 2010
• Last updated: August 19, 2015
• Start date: September 2010
• Est. completion date: January 2016

Study information

• Verified date: August 2015
• Source: Biotech Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationChina: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 144
• Est. completion date: January 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Squamous Cell Carcinoma

Intervention

Drug:
• Nimotuzumab
200mg (4 bottles), once a week for 7 weeks during irradiation (week 1, week 2, week 3, week 4, week 5, week 6 and week 7). After irradiation 200mg (4 bottles), once every 4 weeks for 2 cycles (week 9 and week 13)
• Placebo
4 bottles placebo, once a week for 7 weeks during irradiation (week 1, week 2, week 3, week 4, week 5, week 6 and week 7). After irradiation 200mg (4 bottles), once every 4 weeks for 2 cycles (week 9 and week 13)
• cisplatin
cisplatin 25 mg/m2/d, d1-3, once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13); 5-FU 600 mg/m2/d, d1-3, continuously infusion for 72 hrs,once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13).

Radiation:
• Radiotherapy
A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks. Placebo: 4 bottles placebo, once a week for 7 weeks during irradiation (week 1, week 2, week 3, week 4, week 5, week 6 and week 7). After irradiation 200mg (4 bottles), once every 4 weeks for 2 cycles (week 9 and week 13)

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences Cancer Hospital	Beijing	Beijing
China	The first bethune hospital of Jilin university	Changchun	Jilin
China	Fujian Provincial Tumor Hospital	Fuzhou	Fujian
China	Cancer Center of Sun Yat-sen	Guangzhou	Guangdong
China	The First Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Cancer Hospital of Jiangsu Province	Nanjing	Jiangsu
China	Affiliated Hospital of Qingdao University Medical College	Qingdao	Shandong
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	Shanghai First People's Hospital	Shanghai	Shanghai
China	The First Affiliated Hospital of Soochow University,Suzhou First People's Hospital	Suzhou	Jiangsu
China	Tianjin Cancer Hospital	Tianjin	Tianjin
China	Huazhong University of Science and Technology, Union Hospital, Tongji Medical College	Wuhan	Hubei
China	Fourth Military Medical University Xijing Hospital	Xian	Shanxi
China	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu
China	First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Biotech Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate of Nimotuzumab combined with chemo-irradiation		2 months after radiotherapy	No
Primary	1-yr overall survivals		1 year	No
Primary	2-yr overall survival		2 year	No
Primary	3-yr overall survival		3 years	No
Secondary	Local progression-free survival		3 years	No
Secondary	Disease progression-free survival		3 years	No
Secondary	Distant metastasis rate		3 years	No
Secondary	Number and grade of Participants with Adverse Events		6 months	Yes
Secondary	Quality of life		3 years	No