Esophageal squamous cell carcinoma
Conditions
Interventions
experimental group:camrelizumab for injection, radiotherapy and chemotherapy
Sponsors
Jiangnan University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily participated in the study, signed an informed consent form, had good compliance, and cooperated with visit; 2. Aged 18-75 years, including 18 and 75 years, both male and female; 3. Pathological diagnosis of esophageal squamous cell carcinoma by biopsy, surgically resectable or potentially resectable before admission Stage I, II or IIIA esophageal cancer; 4. Physical fitness score ECOG 0-1 (see attachment 1 for ECOG scoring criteria); 5. According to the evaluation criteria for the efficacy of solid tumors (RECIST1.1), at least one Measure the lesion, and the lesion has not received radiotherapy in the past; 6. The expected survival period is >= 3 months; 7. No serious hematopoietic function, abnormal heart, lung, liver, kidney function and immune deficiency; 8. Neutrophils >= 1.5 x 10^9/L; hemoglobin >= 9g/dL; platelets >= 100 x 10^9/L; total bilirubin <= 1.5 times the upper limit of normal; AST (SGOT) and ALT (SGPT)<= 2.5 times the upper limit of normal; creatinine <= 1.5 times the upper limit of normal.
Exclusion criteria
Exclusion criteria: 1. Perforation of the esophagus or hematemesis; 2. Suffer from any active autoimmune disease or have a history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (hormonal After replacement therapy is effective, it can be included), etc.), and use immunosuppressive agents within 28 days; those with medical history, except for the use of hormones to deal with the toxicity of radiotherapy and chemotherapy; 3. Adverse events greater than grade 2 caused by the treatment received before the first use of the study drug have not recovered (that is, grade 1 or reach the baseline level). According to the judgment of the investigator, adverse events that are difficult to recover quickly (such as neurotoxicity) can be included in the group; 4. According to the judgment of the investigator, non-infectious pneumonia caused by previous radiotherapy and chemotherapy still exists; 5. Have received or are receiving other PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1; 6. Known to be allergic to macromolecular protein preparations, or to any carrelizumab (SHR-1210) and its ingredients; 7. Suffer from uncontrolled cardiac clinical symptoms or diseases, such as: (1) Heart failure above NYHA II; (2) Unstable angina pectoris; (3) Myocardial infarction within 1 year; (4) Clinical significance Supraventricular or ventricular arrhythmia in patients requiring clinical intervention; 8. Suffer from congenital or acquired immune function defects (such as HIV infection), active hepatitis B (HBV-DNA >= 10^4 copies/ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analysis method) Or active tuberculosis; 9. Active infection or fever of unknown cause within 2 weeks before randomization > 38.5 degrees C (according to the judgment of the investigator, the subject can be included in the group for fever caused by tumor); 10. Males or females with fertility are unwilling to take contraceptive measures in the trial, and female patients are pregnant or breastfeeding; 11. As judged by the investigator, the subject has other factors that may cause him to be forced to terminate the study halfway, such as suffering from other serious diseases (including mental illness) requiring combined treatment, family or social factors, which may affect the safety of the subject Or the collection of experimental data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PCR; | — |
Countries
China
Contacts
Public ContactZhang Fuzheng, Weng Yuan
Jiangnan University Hospital
Outcome results
None listed