esophageal squamous cell carcinoma
Conditions
Interventions
Experimental group:Tislelizumab injection
Nimotuzumab injection
paclitaxel for injection (albumin-bound)
Cisplatin injection
Sponsors
Shanxi Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria for enrollment in this study: 1. Signed written informed consent form to voluntarily join this study; 2. Histopathological or cytologically confirmed esophageal squamous cell carcinoma; 3. The patient needs to provide a tissue sample for EGFR detection, and the laboratory confirms that EGFR is overexpressed 4. Thoracic esophageal cancer evaluated by CT/MRI/EUS and the clinical stage is T1b-T2N+M0 or T3-4aNanyM0 (according to AJCC version 8); 5. Those who are expected to achieve R0 resection; 6. Age 18-75 years old, male or female; 7. ECOG PS 0-1; 8. Have not received any anti-tumor therapy for esophageal cancer in the past, including radiotherapy, chemotherapy, surgery, etc.; 9. Planned surgical treatment after completion of neoadjuvant therapy; 10. No contraindications to surgery; 11. Normal function of major organs, including: (1) Routine blood examination (no blood components, cell growth factors, whitening drugs, platelet-raising drugs, anemia correction drugs are allowed within 14 days before the first use of the study drug): White blood cell count >= 4.0×10^9/L Neutrophil count >= 1.5×10^9/L Platelet count >= 100×10^9/L Hemoglobin >= 90 g/L (2) Blood biochemical tests: Total bilirubin = 50 mL/min (Cocheroft-Gault formula) (3) Coagulation: International Normalized Ratio (INR) <= 1.5×ULN ?Activated partial thromboplastin time (APTT) <= 1.5×ULN 12. Female subjects of childbearing potential should have a negative serum or urine pregnancy test within 72 hours prior to starting study drug administration, and use effective contraception (such as intrauterine device, contraceptive pill, or condom) for the duration of the trial and for at least 3 months after the last dose; For male subjects whose partner is a female of childbearing age, effective contraception should be used during the trial and for 3 months after the last dose; The subjects had good compliance and cooperated with follow-up;
Exclusion criteria
Exclusion criteria: Subjects will not be admitted to this study if they have any of the following conditions: 1. The tumor apparently invades an adjacent organ of the esophagus lesion (large artery or trachea); 2. Those with supraclavicular lymph node metastases; 3. Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 4. Poor nutritional status, BMI 10 mg / day of prednisone or equivalent) were being treated for immunosuppression within 2 weeks prior to the first use of the study drug; In the absence of active autoimmune disease, inhaled or topical use of steroids and adrenal gland replacement at doses > 10 mg / day of prednisone or equivalent is permitted; (3) Received a live attenuated vaccine within 4 weeks prior to the first use of the investigational drug; (4) Major surgery or severe trauma within four weeks prior to the first use of the study drug; 7. Has any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered for inclusion after hormone replacement therapy); Those who have had psoriasis or whose childhood asthma / allergies have been in full remission and do not require any intervention in adulthood may be considered for inclusion, but patients requiring medical intervention with bronchiectasis may not be included; 8. A history of immunodeficiency, including HIV-positive or other acquired or congenital immunodeficiency, or a history of organ transplantation or allogeneic bone marrow transplantation; 9. The presence of uncontrollable clinical signs or conditions, including but not limited to: (1) NYHA class II or above heart failure; (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias without or after clinical intervention; 10. Severe infection (CTCAE > 2) occurred within 4 weeks prior to the first use of the investigational drug, such as severe pneumonia, bacteremia, infection complications that required hospitalization; Baseline chest imaging revealed active pulmonary inflammation, signs and symptoms of infection within 14 days prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment, except in cases of preventive antibiotic use; 11. Patients with active pulmonary tuberculosis detected by history or CT, or within 1 year prior to admission, or more than 1 year prior to admission without proper treatment; 12. Presence of active hepatitis B (HBV DNA >= 2000 IU / mL or 10^4 copies / mL), hepatitis C (HCV antibody positive and HCV RNA above the detection limit of analytical methods); 13. Patients whose imaging showed that the tumor had invaded a vital blood vessel during a week or whose investigators determ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathologic complete response, pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event free survival, EFS;Overall survival; | — |
Countries
China
Contacts
Public ContactJianhong Lian/ Hongwei Li
Shanxi Cancer Hospital
Outcome results
None listed