Esophageal cancer
Conditions
Interventions
Experimental group:Tiepefiglatin injection
Sponsors
The First Hospital of Quanzhou City, Fujian Province
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years; 2. The patients with chest esophageal squamous cell carcinoma with local advanced stage (CT3-4NXM0) confirmed by ultrasound gastroscopy /CT/MRI /PET-CT (AJCC eighth edition) and feasible radical surgery; 3. ECOG score 0-2; 4. Expected survival >=12 weeks; 5. Patients who are willing to receive concurrent chemoradiotherapy and choose cisplatin combined with docetaxel as chemotherapy regimen; 6. No serious dysfunction of heart, lung, liver, kidney and other important organs; no jaundice or obstruction of digestive tract; no acute infection was associated; 7. Hematology examination should meet the following standards: white blood cell count >= 3x10^9/L, neutrophil granulocyte >= 1.5x10^9/L, platelet count >= 100x10^9/L d. Hemoglobin >= 100g/ L; 8. The biochemical inspection shall meet the following standards: (1) AST and ALT 60ml/min (Cockcroft-Gault formula); 9. Women of childbearing age must have a pregnancy test (serum) within 7 days before enrolment, and the results should be negative and is willing to use an appropriate method of contraception during the trial and for 8 weeks after the last administration of the experimental drug; For men, surgical sterilization or consent to use an appropriate method of contraception during the trial and for 8 weeks after the last administration of the experimental drug; 10. Patients volunteered to participate in this study, signed informed consent, and showed good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Distant metastasis of the lesion; 2. Patients who are allergic to this product or other genetically engineered E. coli-derived biological products; 3. Before entering the group, received treatment with polyethylene glycol recombinant human granulocyte stimulating factor (PEG-rhG-CSF), recombinant human granulocyte colony stimulating factor (rhG-CSF) and this product; 4. Have a history of other malignant tumors; 5. Known or suspected to be allergic or possibly allergic to chemotherapy drugs platinum and docetaxel; 6. Accompanied by severe heart, liver, and kidney diseases; neurological or mental diseases; or uncontrolled clinical symptoms or diseases of the heart; 7. Serious concomitant diseases are judged by the researcher to affect the safety and compliance of the research; 8. Active infection or fever of unknown cause occurred during the screening period and before the first administration of> 38.5 degrees (according to the judgment of the investigator, the patientt can be included in the group due to the fever caused by the tumor); 9. Use systemic antibiotics within 1 week before starting the study treatment; 10. Receive systemic chemotherapy within 4 weeks; 11. Participated in other drug clinical trials within 4 weeks before enrollment; 12. Have a history of drug abuse and addiction; 13. Pregnant or lactating women; 14. Any bone marrow dysplasia and other abnormal hematopoietic function; 15. The researcher believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of degree >= 3 neutropenia during concurrent radiotherapy and chemotherapy; | — |
Countries
China
Contacts
Public ContactChen Zilong
The First Hospital of Quanzhou City, Fujian Province
Outcome results
None listed