Endostar Combined With NVB and DDP Second-line Treatment of Advanced Esophageal Squamous Cell Carcinomas

Sponsor

Fudan University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02665702

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Esophageal Squamous Cell Carcinoma	Drug: NVB Drug: DDP Drug: Endostar	Phase 2

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

76 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Sep 1, 2018

Anticipated Study Completion Date :

Sep 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Endostar Combined With NVB and DDP Endostar15mg/m2 NVB25 mg/m2 DDP75 mg/m2	Drug: NVB 25mg/m2 ，D1，8 Other Names: Vinorelbine Injection Drug: DDP 75mg/m2 ，D1 or 25mg/m2 D1-3 Other Names: Cisplatin Drug: Endostar 15mg/d，d1-d7 civ Other Names: endo

Arm

Intervention/Treatment

Experimental: Endostar Combined With NVB and DDP

Endostar15mg/m2 NVB25 mg/m2 DDP75 mg/m2

Drug: NVB

25mg/m2 ，D1，8

Other Names:

Vinorelbine Injection

Drug: DDP

75mg/m2 ，D1 or 25mg/m2 D1-3

Other Names:

Cisplatin

Drug: Endostar

15mg/d，d1-d7 civ

Other Names:

endo

Outcome Measures

Primary Outcome Measures

Progression Free Survival [from the first cycle of treatment (day one) to two month after the last cycle]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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