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

Primary Purpose

Squamous Cell Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nimotuzumab
Placebo
cisplatin
Radiotherapy
Sponsored by
Biotech Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma focused on measuring Nimotuzumab, local advanced esophageal squamous cell carcinoma, chemo-irradiation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chinese Academy of Medical Sciences Cancer Hospital
  • Fujian Provincial Tumor Hospital
  • Cancer Center of Sun Yat-sen
  • First Affiliated Hospital of Zhengzhou University
  • Huazhong University of Science and Technology, Union Hospital, Tongji Medical College
  • Cancer Hospital of Jiangsu Province
  • The First Affiliated Hospital of Soochow University,Suzhou First People's Hospital
  • Northern Jiangsu People's Hospital
  • The first bethune hospital of Jilin university
  • Affiliated Hospital of Qingdao University Medical College
  • Fudan University Shanghai Cancer Center
  • Shanghai Chest Hospital
  • Shanghai First People's Hospital
  • Fourth Military Medical University Xijing Hospital
  • Tianjin Cancer Hospital
  • Zhejiang Cancer Hospital
  • The First Affiliated Hospital of College of Medicine, Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nimotuzumab plus chemo-irradiation

Placebo plus chemo-irradiation

Arm Description

Nimotuzumab，chemotherapy(cisplatin )，radiotherapy

Placebo，chemotherapy(cisplatin)，radiotherapy

Outcomes

Primary Outcome Measures

Response rate of Nimotuzumab combined with chemo-irradiation
1-yr overall survivals
2-yr overall survival
3-yr overall survival

Secondary Outcome Measures

Local progression-free survival
Disease progression-free survival
Distant metastasis rate
Number and grade of Participants with Adverse Events
Quality of life

Full Information

First Posted
October 12, 2010
Last Updated
August 19, 2015
Sponsor
Biotech Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01232374
Brief Title
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

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotech Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma
Keywords
Nimotuzumab, local advanced esophageal squamous cell carcinoma, chemo-irradiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nimotuzumab plus chemo-irradiation
Arm Type
Experimental
Arm Description
Nimotuzumab，chemotherapy(cisplatin )，radiotherapy
Arm Title
Placebo plus chemo-irradiation
Arm Type
Placebo Comparator
Arm Description
Placebo，chemotherapy(cisplatin)，radiotherapy
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Nimotuzumab, Placebo
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
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).
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
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)
Primary Outcome Measure Information:
Title
Response rate of Nimotuzumab combined with chemo-irradiation
Time Frame
2 months after radiotherapy
Title
1-yr overall survivals
Time Frame
1 year
Title
2-yr overall survival
Time Frame
2 year
Title
3-yr overall survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Local progression-free survival
Time Frame
3 years
Title
Disease progression-free survival
Time Frame
3 years
Title
Distant metastasis rate
Time Frame
3 years
Title
Number and grade of Participants with Adverse Events
Time Frame
6 months
Title
Quality of life
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Chinese Academy of Medical Sciences Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
266000
Country
China
Facility Name
Fujian Provincial Tumor Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
Facility Name
Cancer Center of Sun Yat-sen
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Huazhong University of Science and Technology, Union Hospital, Tongji Medical College
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Facility Name
Cancer Hospital of Jiangsu Province
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
The First Affiliated Hospital of Soochow University,Suzhou First People's Hospital
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Facility Name
The first bethune hospital of Jilin university
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Affiliated Hospital of Qingdao University Medical College
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201100
Country
China
Facility Name
Shanghai First People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201100
Country
China
Facility Name
Fourth Military Medical University Xijing Hospital
City
Xian
State/Province
Shanxi
ZIP/Postal Code
710000
Country
China
Facility Name
Tianjin Cancer Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Facility Name
The First Affiliated Hospital of College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China

12. IPD Sharing Statement

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

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