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

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

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.

Study Overview

• Status: Unknown
• Conditions: Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Nimotuzumab; Drug: cisplatin; Radiation: Radiotherapy; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 266000
      • Chinese Academy of Medical Sciences Cancer Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • Fujian Provincial Tumor Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Cancer Center of Sun Yat-sen
  • Henan
    • Zhengzhou, Henan, China, 450052
      • First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Huazhong University of Science and Technology, Union Hospital, Tongji Medical College
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Cancer Hospital of Jiangsu Province
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University,Suzhou First People's Hospital
    • Yangzhou, Jiangsu, China, 225001
      • Northern Jiangsu People's Hospital
  • Jilin
    • Changchun, Jilin, China
      • The First Bethune Hospital of Jilin University
  • Shandong
    • Qingdao, Shandong, China, 266000
      • Affiliated Hospital of Qingdao University Medical College
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Fudan University Shanghai Cancer Center
    • Shanghai, Shanghai, China, 201100
      • Shanghai Chest Hospital
    • Shanghai, Shanghai, China, 201100
      • Shanghai First People's Hospital
  • Shanxi
    • Xian, Shanxi, China, 710000
      • Fourth Military Medical University Xijing Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300000
      • Tianjin Cancer Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital of College of Medicine, Zhejiang University
    • Hangzhou, Zhejiang, China, 310000
      • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Nimotuzumab plus chemo-irradiation; Nimotuzumab，chemotherapy(cisplatin )，radiotherapy	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); Drug: 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)
PLACEBO_COMPARATOR: Placebo plus chemo-irradiation; Placebo，chemotherapy(cisplatin)，radiotherapy	Drug: 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); Drug: 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); Other Names: Nimotuzumab, Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
3-yr overall survival	3 years
Response rate of Nimotuzumab combined with chemo-irradiation	2 months after radiotherapy
1-yr overall survivals	1 year
2-yr overall survival	2 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of life	3 years
Local progression-free survival	3 years
Disease progression-free survival	3 years
Number and grade of Participants with Adverse Events	6 months
Distant metastasis rate	3 years

Collaborators and Investigators

• Sponsor: Biotech Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ANTICIPATED): October 1, 2015
• Study Completion (ANTICIPATED): January 1, 2016

Study Registration Dates

• First Submitted: October 12, 2010
• First Submitted That Met QC Criteria: November 1, 2010
• First Posted (ESTIMATE): November 2, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 20, 2015
• Last Update Submitted That Met QC Criteria: August 19, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Nimotuzumab; local advanced esophageal squamous cell carcinoma; chemo-irradiation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Esophageal Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cisplatin; Nimotuzumab
• Other Study ID Numbers: BT-ESO-1001