Continuous Endostar Infusion Combined With Radiotherapy in Esophageal Cancer Patients

Simcere

Status and phase: Unknown; Phase 2

Conditions: Esophageal Cancer

Treatments: Drug: Endostar; Radiation: Radiotherapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01368419

Endu-201105

Details and patient eligibility

About

This study is to explore the clinical efficacy of continuous Endostar infusion combined with radiotherapy in esophageal cancer patients.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological or cytological diagnosis of previously untreated stage I-III esophageal cancer
• Measurable disease according to RECIST criteria
• ECOG Performance Status 0-1
• The length of esophageal carcinoma ≤ 10 cm
• Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 90g/L
• Renal function: Cr ≤ 2.0×UNL
• Hepatic function: BIL ≤ 2.0×UNL, ALT/AST ≤ 5.0×UNL

Exclusion criteria

• Pregnant or lactating women
• Evidence of bleeding diathesis, serious infection
• Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
• Uncontrollable mental and nervous disorders

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Treatment

Experimental group

Treatment:

Radiation: Radiotherapy

Drug: Endostar