Esophageal cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participate , with good compliance, can complete observation and follow-up, and sign informed consent; 2. Histologically confrmed ESCC and classifed as advanced , no anti-tumor drugs other than test drugs in the past 4 weeks, and can receive specialist anti-tumor treatment; 3. At least one measurable lesion (CT examination diameter >= 1cm, other examination methods >= 2cm); 4. ECOG = 3000/µL, absolute count of neutrophils (ANC) >= 1500/µL, platelets >= 100,000/µL, hemoglobin >= 9.0g/dL; (2) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 times the upper limit of normal (ULN), alkaline phosphatase <= 4 times ULN, total bilirubin <= 1.5 times ULN; (3) Serum creatinine <= 1.5 times ULN, the blood urea nitrogen (BUN) <= 2.5 times ULN; (4) Prothrombin time international normalized ratio or partial thromboplastin time <= 1.5 times ULN; (5) Left ventricular ejection fraction (LVEF) greater than or equal to 60% as assessed by Doppler ultrasound; 9. Female: contraception during treatment and 6 months after treatment; non-lactation; male: birth control during the treatment period and within 6 months after the end of treatment.
Exclusion criteria
Exclusion criteria: 1. Pregnancy, lactation, or female patient with fertility without contraception; 2. Serious acute infections, suppurative and chronic infections, and wounds are hard to heal; 3. Esophageal perforation (patients with esophageal tracheal fistula or esophageal fistula), with obvious symptoms and multiple distant metastases; 4. Received other anti-tumor treatments within 4 weeks before enrollment; 5. Abnormal blood coagulation, bleeding tendency (such as active gastrointestinal ulcer) or symptomatic treatment of thrombolysis or anticoagulation; 6. With severe heart disease include: congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction within half a year, severe heart valve disease, and refractory hypertension; 7. Suffering from nervous, mental or mental disorders that are difficult to control, poor compliance, and inability to cooperate with and describe treatment responders; 8. Severe cirrhosis, severe renal insufficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overall survival;Safety;Quality of Life; | — |
Countries
China
Contacts
Chinese PLA General Hospital