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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02665702

Enrollment

Registered

2016-01-28

Start date

2016-01-31

Completion date

2019-09-30

Last updated

2016-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Squamous Cell Carcinoma

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

Interventions

DRUGNVB

25mg/m2 ，D1，8

DRUGDDP

75mg/m2 ，D1 or 25mg/m2 D1-3

DRUGEndostar

15mg/d，d1-d7 civ

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactChang jian Hua, PD

changjianhua@163.com13916619284

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026