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

NCT02665702 | Unknown Phase 2

• 1 other identifier: ENDO-SH-001
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  from the first cycle of treatment (day one) to two month after the last cycle

Study Arms (1)

Endostar Combined With NVB and DDP

EXPERIMENTAL

Endostar15mg/m2 NVB25 mg/m2 DDP75 mg/m2

Drug: NVB; Drug: DDP; Drug: Endostar

Interventions

NVB DRUG

25mg/m2 ，D1，8

Also known as: Vinorelbine Injection

Endostar Combined With NVB and DDP

DDP DRUG

75mg/m2 ，D1 or 25mg/m2 D1-3

Also known as: Cisplatin

Endostar Combined With NVB and DDP

Endostar DRUG

15mg/d，d1-d7 civ

Also known as: endo

Endostar Combined With NVB and DDP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \~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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Cancer hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Vinorelbine; Cisplatin; endostar protein

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Chang jian Hua, PD

CONTACT

13916619284; changjianhua@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: January 28, 2016
• Study Start: January 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2019
• Last Updated: January 28, 2016

Record last verified: 2016-01

Locations

CN (1)