esophagus cancer
Conditions
Sponsors
The Ninth Hospital of the Joint Logistic Support Force of the People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old male or female; 2. ECOG score 0-2; 3. Locally advanced esophageal squamous cell carcinoma confirmed by histopathology; 4. Newly diagnosed patients who did not receive other treatments such as radiotherapy, chemotherapy, targeted therapy or immunotherapy before the clinical trial began; 5. Thoracic esophageal squamous cell carcinoma with local advanced stage (CT3-4NXM0) was clearly diagnosed by ultrasound gastroscopy, CT/MRI and PET-CT, and radical surgery was feasible; 6. According to the efficacy evaluation criteria for solid tumors (RECIST1.1), there should be a target lesion with a measurable diameter locally and/or regionally (long diameter >=10mm on CT scan of tumor lesions, short diameter >=15mm on CT scan of lymph node lesions, scan thickness 5mm); 7. The main organs are normal, without serious dysfunction of heart, lung, liver, kidney and other important organs;No acute infection was associated; No signs of esophageal hemorrhage or perforation; 8. No distant metastasis and resectable; 9. No previous malignant tumors; 10. Expected survival >= 6 months; 11. Hematological examination shall meet the following criteria: A. WBC count >= 3.5 x 10^9/L within 7 days of enrollment B. Neutrophils >= 1.5 x 10^9/L C. Platelet count >= 90 x 10^9/L d. Hemoglobin >= 90g/L 12. Biochemical tests should meet the following criteria: A. ST/ALT 30 g/L E. Serum creatinine 60 mL /min (Cockcroft-Gault formula) F. Lactate dehydrogenase <= 1.5 x ULN 13. Women of childbearing age must have taken a pregnancy test (serum) within 7 days prior to enrolment, be negative, and be willing to take a pregnancy test; Appropriate methods of contraception were used during the trial and 8 weeks after the last administration of the experimental drug;For men, surgical sterilization is recommended; Or agree to use an appropriate method of contraception during the trial and for 8 weeks after the last administration of the experimental drug; 14. Subjects voluntarily participated in this study, signed the informed consent, and showed good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. As a result of previous operations, the stomach cannot be used to replace the esophagus to reconstruct the digestive tract in this operation. 2. Patients diagnosed histologically as esophageal adenocarcinoma; 3. Patients with distant metastasis; 4. The presence or combination of hemorrhagic diseases, esophageal perforation and bleeding signs; 5. Have a history of other malignant tumors; 6. Have received anti-tumor treatment, including chemotherapy, radiotherapy, surgery, immunotherapy, etc.; 7. Known or suspected to be allergic or likely to be allergic to the chemotherapy drugs platinum and albumin paclitaxel; 8. Pregnant or lactating women; 9. Complicated with serious heart, liver and kidney diseases;Neurological and psychiatric diseases; 10. Active infection or unexplained fever of > 38.5 degrees during screening or prior to first administration (subject fever due to tumor can be included as determined by the investigator); 11. Vaccination with live vaccine within 4 weeks prior to study initiation; 12. Systemic antibiotics were used within 1 month before the study began; 13. Gastric or duodenal obstruction; 14. Peripheral sensory neuropathy grade > 1 (including epilepsy and dementia); 15. Failing to cooperate with follow-up and poor compliance; 16. Uncontrolled cardiac clinical symptoms or diseases, such as: (1) Heart failure NYHAII grade 2 or above; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 17. Have a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases; Those whom the investigator considered unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One-year local progression-free rate NPR and pathologic complete response rate PCR after combined chemotherapy; | — |
Countries
China
Contacts
Public ContactYing Wenmin
The Ninth Hospital of the Joint Logistic Support Force of the People's Liberation Army
Outcome results
None listed