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

Last updated: January 24, 2016
Sponsor: Fudan University
Overall Status: Trial Status Unknown

Phase

2

Condition

Carcinoma

Esophageal Cancer

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT02665702
ENDO-SH-001
  • Ages 18-75
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 subsequenttreatment

  14. Prior to biological agents, especially e. coli genetically engineered products withoutsevere allergic reactions

  15. Signed written informed consent

Exclusion

Exclusion Criteria:

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

  2. Chronic diarrhea, enteritis, intestine obstruction which are not under control

  3. Esophageal obstruction cannot eat liquid completely, esophagus have deep ulcerperforation or hematemesis; Esophageal cancer common complications such as anastomoticleakage, 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 heartfailure, unable to control arrhythmia, unstable angina, myocardial infarction, severevalvular heart disease, and resistant hypertension

  6. With uncontrol nerve, mental illness or mental disorders, compliance is poor, can'tcooperate with accounts and response to treatment; Primary brain tumors or CNSmetastases illness did not get a control, has obvious cranial hypertension or nervemental 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

Total Participants: 76
Study Start date:
January 01, 2016
Estimated Completion Date:
September 30, 2019

Study 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

Connect with a study center

  • Cancer hospital Fudan University

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.