Back to resultsEndostar Combined With NVB and DDP Second-line Treatment of Advanced Esophageal Squamous Cell Carcinomas
Primary Purpose
Esophageal Squamous Cell Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
NVB
DDP
Endostar
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Histologically proven primary thoracic esophageal squamous cell carcinoma
- According to the esophageal AJCC2009 7th to determine new stage IV esophageal cancer
- The subject has PD after first-line chemotherapy or radiation within a year
- Presence of at least one index lesion measurable by CT scan or MRI according to RECIST 1.1
- Can eat more than liquid diet; No signs before esophageal perforation
- 18~75 years
- PS:0-1
- Life expectancy of ≥ 3 months
- ANC ≥ 2×109/L，PLT ≥ 100×109/L，Hb ≥ 90g/L
- TB ≤ UNL； ALT/AST ≤ 2.5×UNL，AKP ≤ 5×UNL
- Ccr≤ UNL,Scr≥60 mL/min
- Normal electrocardiogram (ecg), the body had no unheal wounds
- Radiotherapy before within the scope of the normal dose and not affect subsequent treatment
- Prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions
- Signed written informed consent
Exclusion Criteria:
- Breast-feeding or pregnant women, no effective contraception if risk of conception exists
- Chronic diarrhea, enteritis, intestine obstruction which are not under control
- Esophageal obstruction cannot eat liquid completely, esophagus have deep ulcer perforation or hematemesis; Esophageal cancer common complications such as anastomotic leakage, serious lung complications, etc.
- A second primary tumor (except skin basal cell carcinoma)
- The original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension
- With uncontrol nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment; Primary brain tumors or CNS metastases illness did not get a control, has obvious cranial hypertension or nerve mental symptoms
- With bleeding tendency
- Has inherited bleeding evidence of physical or blood coagulation disorder
- With clear chemotherapy drug allergy
- Other researchers believe that patients should not participate in this testing
Sites / Locations
- Cancer hospital Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endostar Combined With NVB and DDP
Arm Description
Endostar15mg/m2 NVB25 mg/m2 DDP75 mg/m2
Outcomes
Primary Outcome Measures
Progression Free Survival
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02665702
Brief Title
Endostar Combined With NVB and DDP Second-line Treatment of Advanced Esophageal Squamous Cell Carcinomas
Official Title
Endostar Combined With NVB and DDP Second-line Treatment of Advanced Esophageal Squamous Cell Carcinomas of the Prospective, Single Arm Phase II Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to explore whether endostar combined with NVB and DDP as treatment could improve progression-free surial time (PFS) and to evaluate the safety of the chemotherapy regimens
Detailed Description
This study is to explore whether endostar combined with NVB and DDP as treatment could improve progression-free surial time (PFS) and to evaluate the safety of the chemotherapy regimens used as second-line treatment of advanced esophageal squamous cell carcinomas
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endostar Combined With NVB and DDP
Arm Type
Experimental
Arm Description
Endostar15mg/m2 NVB25 mg/m2 DDP75 mg/m2
Intervention Type
Drug
Intervention Name(s)
NVB
Other Intervention Name(s)
Vinorelbine Injection
Intervention Description
25mg/m2 ，D1，8
Intervention Type
Drug
Intervention Name(s)
DDP
Other Intervention Name(s)
Cisplatin
Intervention Description
75mg/m2 ，D1 or 25mg/m2 D1-3
Intervention Type
Drug
Intervention Name(s)
Endostar
Other Intervention Name(s)
endo
Intervention Description
15mg/d，d1-d7 civ
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
from the first cycle of treatment (day one) to two month after the last cycle
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:
Histologically proven primary thoracic esophageal squamous cell carcinoma
According to the esophageal AJCC2009 7th to determine new stage IV esophageal cancer
The subject has PD after first-line chemotherapy or radiation within a year
Presence of at least one index lesion measurable by CT scan or MRI according to RECIST 1.1
Can eat more than liquid diet; No signs before esophageal perforation
18~75 years
PS:0-1
Life expectancy of ≥ 3 months
ANC ≥ 2×109/L，PLT ≥ 100×109/L，Hb ≥ 90g/L
TB ≤ UNL； ALT/AST ≤ 2.5×UNL，AKP ≤ 5×UNL
Ccr≤ UNL,Scr≥60 mL/min
Normal electrocardiogram (ecg), the body had no unheal wounds
Radiotherapy before within the scope of the normal dose and not affect subsequent treatment
Prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions
Signed written informed consent
Exclusion Criteria:
Breast-feeding or pregnant women, no effective contraception if risk of conception exists
Chronic diarrhea, enteritis, intestine obstruction which are not under control
Esophageal obstruction cannot eat liquid completely, esophagus have deep ulcer perforation or hematemesis; Esophageal cancer common complications such as anastomotic leakage, serious lung complications, etc.
A second primary tumor (except skin basal cell carcinoma)
The original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension
With uncontrol nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment; Primary brain tumors or CNS metastases illness did not get a control, has obvious cranial hypertension or nerve mental symptoms
With bleeding tendency
Has inherited bleeding evidence of physical or blood coagulation disorder
With clear chemotherapy drug allergy
Other researchers believe that patients should not participate in this testing
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chang jian Hua, PD
Phone
13916619284
Email
changjianhua@163.com
Facility Information:
Facility Name
Cancer hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang jian hua, PD
Phone
13916619284
Email
changjianhua@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Endostar Combined With NVB and DDP Second-line Treatment of Advanced Esophageal Squamous Cell Carcinomas
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