Esophageal squamous cell carcinoma
Conditions
Interventions
Experience group:Sindelimab+Paclitaxel Liposome+Carboplatin
Sponsors
Jiangsu Cancer Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Voluntary participation and written signature of informed consent; 2) Aged 18-75 years, gender is not limited; 3) Histologically confirmed thoracic esophageal squamous cell carcinoma; 4) Clinical stage: stage II-III (cT1N1M0 or cT2-3N0-1M0) (UICC 6th, see Annex 1); 5) There was no disease progression before admission. 6) Physical condition score ECOG 0-1 (ECOG score standard see Annex 2); 7) Expected survival period (> 3 months); 8) No serious hematopoietic dysfunction, heart, lung, liver and kidney dysfunction and immune deficiency were found. Neutrophils (>= 1.5 *10^9/L); hemoglobin (>= 9g/dL); platelets (>= 100 *10^9/L); total bilirubin (<= 1.5 times normal value upper limit); AST (SGOT) and ALT (SGPT) (<= 2.5 times normal value upper limit); creatinine (<= 1.5 times normal value upper limit).
Exclusion criteria
Exclusion criteria: 1) Esophageal perforation or hematemesis; 2) Have any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, glomerulonephritis, hyperthyroidism, hypothyroidism, etc.) and use immunosuppressive agents within 28 days. Patients with medical history, except hormones used to treat toxicity caused by radiotherapy and chemotherapy; 3) Adverse events (such as neurotoxicity) that are difficult to recover quickly can be grouped according to the judgement of the researchers. 4) Have received or are receiving other PD-1 antibody therapy or other immunotherapy for PD-1/PD-L 1; 5) Known allergies to macromolecule protein preparations, or to any of the constituents of Sindelimab and its preparations; 6) Patients with uncontrolled cardiac symptoms or diseases, such as: (1) heart failure above NYHA level II; (2) unstable angina pectoris; (3) myocardial infarction within one year; (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 7) Infected with congenital or acquired immunodeficiency (e.g. HIV-infected persons), active hepatitis B (HBV-DNA (> 104 copies/ml), or hepatitis C (HCV-RNA positive, and HCV-RNA higher than the lower limit of the analysis method) or active tuberculosis; 8) Active infection or unexplained fever in the first two weeks of randomization > 38.5 degree C (according to the judgement of the researcher, the fever caused by tumors can be included in the group). 9) Fertile males or females are reluctant to take contraceptive measures in the trial, and females are pregnant or lactating. According to the judgement of the researchers, there are other factors that may lead to the forced termination of the study, such as the need for combined treatment for other serious diseases (including mental disorders), family or social factors, which may affect the safety of the subjects or the collection of experimental data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate of operation;; | — |
Secondary
| Measure | Time frame |
|---|---|
| Over survial;Disease-free survival time; | — |
Countries
China
Contacts
Public ContactJinjun Ye
Jiangsu Cancer Hospital
Outcome results
None listed