Esophageal squamous cell carcinoma
Conditions
Interventions
Queue 1 Observation Group A:NA
Queue 1 Immunotherapy Group B:NA
Queue 2 Observation Group C:NA
Queue 2 Radiotherapy Group D:NA
Sponsors
Army Medical Center of PLA
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patients must have the ability to understand and voluntarily sign informed consent forms; 2. Age: 18-80 years old; 3. Preoperative clinical staging of esophageal squamous cell carcinoma in stages II-III (excluding cT2N0)(TNM 8th stage) patients. 4. Preoperative treatment with Carolizumab, paclitaxel, and platinum chemotherapy 2-4Period; 5. ECOG PS score: 0-2; 6. Received radical surgical treatment and achieved R0 resection; 7. The intraoperative lymph node dissection method is complete two field lymph node dissection of the chest and abdomen; 8. Good compliance and ability to follow up. 9. Have not participated in any other drug clinical trials within the first 4 weeks of enrollment
Exclusion criteria
Exclusion criteria: 1. Participated in another clinical study administration within the past 4 weeks; 2. The intraoperative lymph node dissection method is three-field lymph node dissection; 3. Patients with residual tumors and distant metastases; 4. History of cardiovascular disease: Congestive heart failure>New York Heart Association (NYHA) standard level II, patients with active coronary artery disease (those who have experienced myocardial infarction 6 months before enrollment can be enrolled), arrhythmias that require treatment (allowed to be taken) ß Receptor blockers or digoxin; 5. Active severe clinical infection (>NCI-CTCAE 5.0 Level 2 infection standard), including tuberculosis (clinical evaluation, including clinical history, physical examination, imaging findings and TB examination in line with local clinical practice), hepatitis B B (known positive for HBV surface antigen [HbsAg]), hepatitis C or human immunodeficiency virus (HIV 1/2 antibody positive). Previous HBV infection or cured (defined as the presence of hepatitis B Patients with core IgG antibodies and no HBsAg are eligible. Patients who test positive for hepatitis C virus (HCV) antibodies are eligible only if they test negative for HCV RNA polymerase chain reaction; 6. History of allogeneic organ transplantation; 7. Patients with bleeding tendencies or coagulation disorders (14 days before randomization must meet the INR within the normal range without using anticoagulants); 8. Patients who require kidney dialysis; 9. Other tumors other than esophageal cancer that were previously diagnosed within 5 years prior to enrollment in this study. Exclusions: cervical carcinoma in situ, cured basal cell carcinoma, and cured bladder epithelial tumors; 10. Patients with interstitial pneumonia; 11. A history of hemorrhagic disease = CTCAE level 2 within 4 weeks prior to the first use of the study drug, including but not limited to the following: pulmonary hemorrhage; Local active ulcer lesions with fecal occult blood (++); Individuals with a history of black stools and hematemesis within 2 months; Researchers believe that there may be significant gastrointestinal bleeding; 12. Severe untreated wounds, ulcers, or fractures; 13. Uncorrected dehydration; 14. Pregnant or lactating patients; 15. Drug abuse and medical, psychological, or social conditions may interfere with patient participation in research or have an impact on the evaluation of research results; 16. Known or suspected to be allergic to the test drug or to any medication administered in connection with this experiment; 17. Any unstable condition that may endanger the patient's safety and affect their compliance with the study; 18. Patients with poor compliance; 19. Researchers believe that it is not appropriate to participate in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1year DFS rate;2year DFS rate;OS; | — |
Countries
China
Contacts
Public ContactMengxia Li
Army Medical Center of PLA
Outcome results
None listed