Esophageal squamous cell carcinoma and gastroesophageal junction carcinoma
Conditions
Interventions
Immunization group:Camrelizumab + chemotherapy after surgery
Single free group:Carrelizumab alone after surgery
preoperative group:Camrelizumab + chemotherapy before surgery
Sponsors
Shanxi Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, both male and female; 2. Patients with perioperative esophageal cancer (stage II, III) and gastroesophageal junction cancer (type I, II) diagnosed by histology or cytology; 3. At least one measurable lesion in imaging examination (RECIST1.1 standard), spiral CT or MR target lesion should be >=10 mm, and lymph node >= 15mm; 4. Have not received systemic anti-tumor therapy in the past; 5. Estimated survival time >= 3 months; 6.ECOG= 45ml/min; e. Hemoglobin Hb >= 90g/L; f. Absolute neutrophil count ANC >= 1.5 x 10^9/L; g. Platelet count PLT >= 80 x 10^9/L; h. Albumin ALB >= 29g/L; i. Have not received anticoagulant treatment; the coagulation parameters of using anticoagulant should be within the expected range; j. Coagulation function International standardized value INR <= 1.5 x ULN; k. Activated partial thromboplastin time APTT <= 1.5 x ULN; 8. Normal urine and stool routine; 9. The wound of the subject has completely healed after the operation, and there is no bleeding tendency; 10. Female subjects with fertility should undergo a urine or serum pregnancy test within 72 hours before receiving the first study drug administration, and prove to be negative, and are willing to administer carrelizumab during the trial period to the last time Use effective methods of contraception within the next 3 months. For male subjects whose partners are women of childbearing age, effective methods of contraception should be used during the trial and within 3 months after the last administration of carrelizumab; 11. Volunteer to join; compliance is good, willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Subjects who are going to undergo or have received tissue/organ transplantation in the past; 2. Subjects with any active, known or suspected autoimmune disease; 3. Treated with corticosteroids (>10 mg/day of prednisone or equivalent) or other immunosuppressive agents. In the absence of active immune disease, inhaled or topical steroids and epinephrine replacement at therapeutic doses >10 mg/day of prednisone are permitted; 4. Subjects who have been treated with anti-tumor vaccines or other anti-tumor drugs (interferon, interleukin, thymosin, immune cell therapy, etc.) within 1 month before the first dose; vaccinated within 30 days before the first dose or subjects to be vaccinated with live vaccines; 5. Those who have undergone major surgical operations within 4 weeks before the first medication; 6. Known uncontrolled or symptomatic active central nervous system (CNS) metastases manifested by clinical symptoms, cerebral edema, spinal cord compression, cancerous meningitis, leptomeningeal disease and/or progressive growth. Patients with a history of central nervous system metastases or spinal cord compression can be enrolled in the study if they are clearly treated and clinically stable after 4 weeks of discontinuation of anticonvulsants and steroids before the first dose of the study; 7. Within 6 months before entering the study, the following conditions have occurred: severe/unstable angina pectoris, myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia (including QTc interval >= 450 ms in men, >= 450 ms in women) 470 ms) subjects. Subjects with LVEF (left ventricular ejection fraction) = 2000 IU/mL; Hepatitis C: Hepatitis C virus antibody (HCV Ab) positive, HCV RNA positive, and abnormal liver function; Hepatitis B and hepatitis C co-infection ; 11. Subjects with severe infection within 4 weeks before the first dose, including but not limited to infection complications requiring hospitalization, bacteremia, severe pneumonia, etc. Subjects with any active infection were excluded; 12. Known to have a positive history of human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS); 13. Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 14. Subjects with organ attenuation caused by radiotherapy; 15. Subjects with chemotherapy-related contraindications in the past; 16. Severe allergic reactions to other monoclonal antibodies; 17. Pregnant or lactating women; 18. Subjects with mental illness, alcoholism, inability to quit smoking, drug addiction or drug abuse; the investigator judges other conditions that may affect the conduct of clinical research and the judgment of research results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response Rate (MPR);R0 resection rate;pathological complete response rate; | — |
Countries
China
Contacts
Public ContactZhang Shuangping
Shanxi Cancer Hospital
Outcome results
None listed