esophageal cancer
Conditions
Interventions
experimental group :Recombinant humanized anti-PD-1 monoclonal antibody combined with docetaxel and cisplatin neoadjuvant therapy
Sponsors
Fujian Medical University Union Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Resectable esophageal carcinoma (squamous carcinoma, adenocarcinoma, adenosquamous carcinoma) proved by pathology (including histology or cytology); 3. Esophageal cancer stage >= cT3 or >= N+ was confirmed by CT/MRI or color ultrasound, PET-CT or ultrasonic gastroscopy before surgery; 4. Newly diagnosed patients without prior surgery, radiotherapy and chemotherapy, targeted therapy, immunotherapy and other treatments; 5. ECOG PS: 0-2 points; 6. No serious heart, lung or liver dysfunction; No acute infection; 7. The main organs function normally and meet the following standards: (1) blood routine examination criteria must be met :(no blood transfusion within 14 days) a.HB 100 g/L or higher, b.WBC acuity 3.5 x 10^9 / L c.ANC acuity 1.5 x 10^9 / L, d.PLT 100 x 10^9 /L or higher; (2) Biochemical tests shall meet the following standards: a.BIL 60ml/min (Cockcroft Gault formula) 8. Not participating in other clinical studies within 3 months before treatment; 9. Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous surgical history of thoracic malignant tumor; 2. Prior systemic antitumor therapy, including radiotherapy, cytotoxic drugs, targeted drugs, monoclonal antibodies, or experimental therapy; Patients who had taken anti-tumor Chinese herbal medicine within 7 days prior to enrollment; 3. Small cell carcinoma or distant metastasis; Patients with tumor invasion of cervical esophagus or upper thoracic segment requiring laryngectomy. 4. Accompanied by serious heart, liver and kidney diseases; Neurological and mental diseases; With severe infection; 5. Pregnant or lactating women; 6. Patients with hypertension who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 7. Patients with grade ? or above coronary heart disease, arrhythmia (including prolonged QTc interval > 450 ms in males and > 470 ms in females) and cardiac insufficiency; 8. Patients with high risk of bleeding or perforation due to obvious tumor invasion of adjacent organs (major arteries or trachea) of esophageal lesions, or patients who have developed fistulas; 9. Known to have interstitial lung disease requiring steroid therapy and active pulmonary tuberculosis; There is a known history of primary immunodeficiency. Or have an active autoimmune disease requiring symptomatic treatment or a history of the disease within 2 years. 10. The patient has a history of severe allergy, anaphylaxis, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; 11. Patients who have previously received allogeneic stem cell or solid organ transplantation; 12. Researchers considered it unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 section rate; | — |
Countries
China
Contacts
Public ContactMingqiang Kang
Fujian Medical University Union Hospital
Outcome results
None listed