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

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Drug: Endostar; Drug: DDP; Drug: NVB

Study type: Interventional

Funder types: Other

Identifiers

NCT02665702

ENDO-SH-001

Details and patient eligibility

About

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

Full 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

Enrollment: 76 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 1 patient group

Endostar Combined With NVB and DDP

Experimental group

Description:

Endostar15mg/m2 NVB25 mg/m2 DDP75 mg/m2

Treatment:

Drug: NVB

Drug: DDP

Drug: Endostar