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

• Status: Unknown status
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Cisplatin; Endostar protein; Vinorelbine

Criteria

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