esophageal cancer
Conditions
Interventions
2 Period :Number of cycles
3 period:Number of cycles
Sponsors
Jining NO1 People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Signed written informed consent before enrollment; 2) Age 18-75, male or female; 3) Newly treated subjects with esophageal squamous cell carcinoma confirmed by pathology and imaging; Stage: cT1-3N1-2M0, cT2-3N0M0 (stage ?/?), clinical stage of AJCC eighth edition of esophageal squamous cell carcinoma; 4) R0 resection can be performed by pre-treatment evaluation; 5) No suspicious metastatic lymph nodes indicated by cervical color ultrasound; 6) Measurable lesions that meet RECIST v1.1 criteria for evaluation; 7)ECOG score: 0 ~ 1; 8)The subjects voluntarily participated in the study with good compliance and safety and survival follow-up.
Exclusion criteria
Exclusion criteria: Patients with any of the following criteria were not enrolled in this study 1) Prior radiotherapy, chemotherapy, long-term or high-dose hormone therapy, surgery, or molecular targeted therapy; 2) The subject has had or is suffering from other malignant tumors; 3) Previous treatment with other PD-1/PD-L1; The subject is known to have a prior allergy to macromolecular protein preparations, or to any PD-1 component; 4) The subject has any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects who had vitiligo or had complete remission of asthma in childhood could be included without any intervention as adults; Patients with asthma requiring medical intervention with bronchodilators are not included); 5) Subjects were taking immunosuppressive drugs for immunosuppressive purposes and continued to use them within 2 weeks prior to enrollment; 6) Patients with poorly controlled cardiac clinical symptoms or diseases, such as: (1) NYHA2 + heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 7) Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg>2g/L), bleeding tendency or receiving thrombolytic or anticoagulant therapy; 8) The patient currently (within 3 months) has gastrointestinal diseases such as esophageal varicose veins, active gastric and duodenal ulcers, ulcerative colitis, portal hypertension, or active bleeding from unexcised tumors, or other conditions determined by researchers that may cause gastrointestinal bleeding or perforation; 9) Previous or current severe bleeding (bleeding >30 ml within 3 months), hemoptysis (fresh blood >5 ml within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attacks) within 12 months; 10) Subjects had an active infection or unexplained fever >38.5 degrees during the screening period and prior to initial administration. 11) Abdominal fistula, gastrointestinal perforation, or abdominal abscess occurred less than 4 weeks before study administration; 12) Patients with prior or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe impairment of lung function; 13) Subjects with congenital or acquired immune dysfunction, such as HIV infection, or active hepatitis (transaminase did not meet the inclusion criteria, hepatitis B reference: HBV DNA=104/ml; HCV reference: HCV RNA=103/ml); Chronic hepatitis B virus carriers, HBV DNA=2000 IU/ml (=104 copies /ml), must also receive antiviral therapy during the trial to be enrolled; 14) The subject is unable or does not agree to bear the out-of-pocket costs of examination and treatment; 15. For example, the subjects have other factors that, in the judgment of the investigators, may lead to the termination of the study, such as other serious medical conditions (including mental illness) requiring combined treatment, serious abnormalities in laboratory tests, family or social factors that may affect the safety of the subjects, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Pathological response rate;PFS;secrity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of surgery; | — |
Countries
china
Contacts
Public ContactCai Haibo
Jining NO1 People's Hospital
Outcome results
None listed