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

Esophageal Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02665702
• Other study ID #: ENDO-SH-001
• Status: Recruiting
• Phase: Phase 2
• First received: January 19, 2016
• Last updated: January 24, 2016
• Start date: January 2016
• Est. completion date: September 2019

Study information

• Verified date: January 2016
• Source: Fudan University
• Contact: Chang jian Hua, PD
• Phone: 13916619284
• Email: changjianhua[@]163.com
• Is FDA regulated: No
• Health authority: China: Fudan University Cancer Center IRB (Institutional Review Board)
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: September 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• NVB
25mg/m2 ,D1,8
• DDP
75mg/m2 ,D1 or 25mg/m2 D1-3
• 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	No