Endostar Combined With NVB and DDP Second-line Treatment of Advanced Esophageal Squamous Cell Carcinomas
NCT ID: NCT02665702
Last Updated: 2016-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
76 participants
INTERVENTIONAL
2016-01-31
2019-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Endostar Combined With NVB and DDP
Endostar15mg/m2 NVB25 mg/m2 DDP75 mg/m2
NVB
25mg/m2 ，D1，8
DDP
75mg/m2 ，D1 or 25mg/m2 D1-3
Endostar
15mg/d，d1-d7 civ
Interventions
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NVB
25mg/m2 ，D1，8
DDP
75mg/m2 ，D1 or 25mg/m2 D1-3
Endostar
15mg/d，d1-d7 civ
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. According to the esophageal AJCC2009 7th to determine new stage IV esophageal cancer
3. The subject has PD after first-line chemotherapy or radiation within a year
4. Presence of at least one index lesion measurable by CT scan or MRI according to RECIST 1.1
5. Can eat more than liquid diet; No signs before esophageal perforation
6. 18\~75 years
7. PS:0-1
8. Life expectancy of ≥ 3 months
9. ANC ≥ 2×109/L，PLT ≥ 100×109/L，Hb ≥ 90g/L
10. TB ≤ UNL； ALT/AST ≤ 2.5×UNL，AKP ≤ 5×UNL
11. Ccr≤ UNL,Scr≥60 mL/min
12. Normal electrocardiogram (ecg), the body had no unheal wounds
13. Radiotherapy before within the scope of the normal dose and not affect subsequent treatment
14. Prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions
15. Signed written informed consent
Exclusion Criteria
2. Chronic diarrhea, enteritis, intestine obstruction which are not under control
3. 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.
4. A second primary tumor (except skin basal cell carcinoma)
5. 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
6. 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
7. With bleeding tendency
8. Has inherited bleeding evidence of physical or blood coagulation disorder
9. With clear chemotherapy drug allergy
10. Other researchers believe that patients should not participate in this testing
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Chang Jian Hua
Chief Physician
Locations
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Cancer hospital Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ENDO-SH-001
Identifier Type: -
Identifier Source: org_study_id
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