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

Phase 2

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Drug: NVB; Drug: DDP; Drug: Endostar

• Registration Number: NCT02665702
• Lead Sponsor: Fudan University

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

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 Timeline

• Status Verified: 2016-01
• Study Start: 2016-01
• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-01-24
• Last Update Submitted: 2016-01-24
• Study First Posted: 2016-01-28
• Last Update Posted: 2016-01-28
• Primary Completion: 2018-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endostar Combined With NVB and DDP	DDP	Endostar15mg/m2 NVB25 mg/m2 DDP75 mg/m2
Endostar Combined With NVB and DDP	NVB	Endostar15mg/m2 NVB25 mg/m2 DDP75 mg/m2
Endostar Combined With NVB and DDP	Endostar	Endostar15mg/m2 NVB25 mg/m2 DDP75 mg/m2

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	from the first cycle of treatment (day one) to two month after the last cycle

Trial Locations

Locations (1)

Cancer hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China