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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03797625
Other study ID # ENDO-SH-002
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 4, 2017
Est. completion date December 31, 2021

Study information

Verified date January 2019
Source Fudan University
Contact chang jian hua, PD
Phone 18017312689
Email changjianhua@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to explore whether endostar combined with IP as treatment could improve progression-free surial time (PFS) and to evaluate the safety of the chemotherapy regimens


Description:

This study is to explore whether endostar combined with IP 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


Recruitment information / eligibility

Status Recruiting
Enrollment 76
Est. completion date December 31, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Irinotecan
60mg/m2,D1,8
DDP
60mg/m2,D1
Endostar
15mg/d,d1-d7 civ

Locations

Country Name City State
China Cancer hospital Fudan University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival from the first cycle of treatment (day one) to two month after the last cycle
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