esophageal cancer
Conditions
Interventions
2-cycle treatment group:None
3-cycle treatment group:None
Sponsors
Jining No.1 People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Voluntary participation and signing of informed consent form; 2.Age range: 18-75 years old, both male and female are eligible; 3.Newly diagnosed subjects with esophageal squamous cell carcinoma diagnosed by pathology and imaging; Installment: CT1N1-2M0, cT2-3N0-2M0, cT4AN0-1M0 (stage II/III), AJCC 8th edition clinical staging of esophageal squamous cell carcinoma; 4.Pre treatment evaluation can result in R0 surgical resection; Neck ultrasound shows no suspicious metastatic lymph nodes; 5.Measurable lesions that meet the RECIST v1.1 standard for evaluation; 6.The subjects voluntarily joined this study, showed good compliance, and cooperated with safety and survival follow-up.
Exclusion criteria
Exclusion criteria: 1.Patients who refuse to sign informed consent forms to participate in the experiment; 2.Previously received radiation therapy, chemotherapy, long-term or high-dose hormone therapy, surgery, or molecular targeted therapy; 3.Imaging confirms distant metastasis in patients; 4.The subject has a history or concurrent presence of other malignant tumors; 5.Previous PD-1/PD-L1 treatment cannot be included in the group; It is known that the subject has a history of allergies to macromolecular protein preparations or any PD-1 components; 6.Subjects with any active autoimmune disease or history of autoimmune disease (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or complete remission of childhood asthma without intervention in adulthood; subjects with asthma requiring intervention with bronchodilators cannot be included); 7.Ascites or pleural effusion with clinical symptoms requiring therapeutic puncture or drainage; 8.Patients with uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHA grade 2 or above heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 9.Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg>2g/L), with bleeding tendency or currently receiving thrombolytic or anticoagulant therapy; 10.The patient currently (within 3 months) has digestive tract diseases such as esophageal varices, active ulcers in the stomach and duodenum, ulcerative colitis, portal hypertension, or active bleeding from unresected tumors, or other conditions determined by the researchers that may cause gastrointestinal bleeding or perforation; 11.Previous or current severe bleeding (>30 ml within 3 months), hemoptysis (>5 ml of fresh blood within 4 weeks), or thromboembolic events (including stroke and/or transient ischemic attack) within 12 months; 12.Having experienced abdominal fistula, gastrointestinal perforation, or abdominal abscess less than 4 weeks prior to medication use in the study; 13.Patients with objective evidence of past and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of lung function, etc; 14.Subjects with congenital or acquired immune function defects, such as HIV infected persons, or active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA>=104/ml; Hepatitis C reference: HCV RNA=103/ml); Chronic carriers of hepatitis B virus with HBV DNA >= 2000 IU/ml (>= 104 copies/ml) must receive antiviral treatment during the experiment in order to be enrolled; 15.The subjects are currently participating in other clinical studies or have been less than one month since the end of the previous clinical study; Participants may receive other systemic anti-tumor treatments during the study period; 16.Less than 4 weeks before the study medication or may receive live vaccine during the study period; 17.The researchers believe that participants should be excluded from this study, for example, if the researchers determine that there are other factors that may cause the study to be terminated midway, such as other serious illnesses (including mental illnesses) that require concomitant treatment, serious laboratory
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ratio of PCR and MPCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;progression-free survival; | — |
Countries
China
Contacts
Public ContactZhang Shifa
Jining No.1 People's Hospital
Outcome results
None listed