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

Endostar Combined With NVB and DDP Second-line Treatment of Advanced Esophageal Squamous Cell Carcinomas of the Prospective, Single Arm Phase II Clinical Study

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

Study Overview

• Status: Unknown
• Conditions: Esophageal Squamous Cell Carcinoma
• Intervention / Treatment: Drug: NVB; Drug: DDP; Drug: Endostar

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 Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chang jian hua, PD; Phone Number: 13916619284; Email: changjianhua@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Cancer hospital Fudan University
      • Contact: Chang jian hua, PD; Phone Number: 13916619284; Email: changjianhua@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Histologically proven primary thoracic esophageal squamous cell carcinoma
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:

1. Breast-feeding or pregnant women, no effective contraception if risk of conception exists
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression Free Survival	from the first cycle of treatment (day one) to two month after the last cycle

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (ANTICIPATED): September 1, 2018
• Study Completion (ANTICIPATED): September 1, 2019

Study Registration Dates

• First Submitted: January 19, 2016
• First Submitted That Met QC Criteria: January 24, 2016
• First Posted (ESTIMATE): January 28, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): January 28, 2016
• Last Update Submitted That Met QC Criteria: January 24, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Esophageal Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Cisplatin; Vinorelbine; Endostar protein
• Other Study ID Numbers: ENDO-SH-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED