Oesophageal carcinoma
Conditions
Interventions
Control group :Concurrent chemoradiotherapy
Experimental group :Apatinib+Concurrent chemoradiotherapy
Sponsors
Department of Radiation Oncology, the Third Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Male or female, Aged 18-70 years; 2) Patients are volunteered to participate in clinical trials, and sign a written informed consent; 3) Eastern cooperative oncology group (ECOG) physical condition score 0-1, life expectancy > 3 months; 4) Esophageal squamous cell carcinoma was confirmed by postoperative pathological diagnosis; 5) Patient have previously received R0 resection for esophageal cancer. The time for diagnosing with lymph nodes recurrence was at least 6 months from the surgery. 6) Recurrent lymph nodes are located in the neck, mediastinum, para-aorta and other common lymph node metastases sites, which could be measured and evaluated by CT or MRI.The first CT/MRI examination is completed within 1 week before enrollment. The measurments of lymph nodes are recorded as the baseline for efficacy evaluation. 7) Patients could tolerate the combined treatment; 8) Biochemical test indexes must meet the following standards before enrollment: a. WBC count 2.0x10^9/L b. Neutrophil count 1.5x10^9/L c. Platelet count 100x10^9/L d. Hemoglobin 90g/L e. alanine aminotransferase and straw aminotransferase 45 ml/min (Cockcroft-Gault).
Exclusion criteria
Exclusion criteria: 1) Patients have been diagnosed with malignant tumor from other tissue types; 2) Patients have been diagnosed with intracranial metastasis, bone metastasis or visceral metastasis; 3) Patients have previously received drug targeted to VEGF, VEGFR or related signaling protein targets (such as RAF kinase); 4) Patients with uncontrolled hypertension (systolic blood pressure > 150mmHg, diastolic blood pressure > 90mmHg); 5) Patients with bleeding tendency, such as unhealed wounds, active peptic ulcer, abnormal coagulation function, etc.; 6) Patients with uncontrolled infection, grade II or above heart failure, unstable angina, frequent arrhythmia, and a history of cardiovascular and cerebrovascular infarction within 1 year; 7) Patients with schizophrenia and other mental disorders which can affect treatment compliance; 8) Patients with acute or chronic infectious diseases, such as hepatitis B, hepatitis C, tuberculosis and HIV; 9) Patients are allergy to the ingredients of study drug; 10) Patients are considered to be unsuitable for combination therapy for other unlisted reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate;Overall Survival;Tolerance and Adverse Event;Quality of Life; | — |
Countries
China
Contacts
Public ContactGu Wendong
Department of Radiation Oncology, the Third Affiliated Hospital of Soochow University
Outcome results
None listed