sequential preoperative penpulimab combined with chemoradiotherapy(crt) for locally advanced esophageal squamous cell cancer

Conditions: Esophageal Squamous Cell Carcinoma

Summary: this study used an open single center study design to observe the efficacy and safety of penpulimab combined with chemoradiotherapy(crt) in preoperative t2,3,4an0-1-2m0 esophageal squamous cell carcinoma (escc).


Eligibility criteria:
inclusion criteria: * resectable t2,3,4an0-1-2m0 esophageal squamous cell carcinoma initially diagnosed by histology or cytology; * without any systematic anti-tumor treatment; * ecog 0-1; * anc≥ 1.5×109/l; * plt≥ 75×109/l; * hb≥ 8.0 g/dl; * tbil ≤ 1.5´ uln; * alt and ast ≤ 2.5´uln; * cr ≤ 1.5´uln or ccr ≥ 60ml/min; * urine protein \< +, if urine protein + then the total protein in 24 hours must be \<500mg; * blood glucose is within the normal range and / or patients with diabetes are in treatment, but blood glucose is controlled in a stable state; * fev1 ≥ 2l; if the baseline fev1 is less than 2l, it is estimated that the fev1 after surgery is greater than 800ml； * no myocardial infarction within 1 year; no unstable angina pectoris; no symptomatic severe arrhythmia; no cardiac insufficiency； * there are no serious complications or other major diseases that have not been cured； * thoracic surgeons judge those who can tolerate the operation； * female subjects with fertility and male subjects with partners of childbearing age need to use a medically approved contraceptive measure during the study treatment and at least 6 months after the last chemotherapy； * the subjects voluntarily joined the study and signed the informed consent form exclusion criteria: * received any kind of systematic anti-tumor treatment before the first use of the study drug； * at the same time, another clinical study will be included, unless it is an observational (non intervention) clinical study； * subjects who need to be given corticosteroids (more than 10mg prednisone equivalent dose per day) or other immunosuppressants for systematic treatment within 2 weeks before the first use of the study drug； * have been vaccinated with tumor vaccine or have been vaccinated with live vaccine within 4 weeks before administration； * have a history of active autoimmune diseases and autoimmune diseases; except for patients who have recovered from childhood asthma / allergy and do not need any intervention after adulthood; autoimmune mediated hypothyroidism treated with a stable dose of thyroid hormone replacement; use a stable dose of insulin for type i diabetes； * serious interference occurred within 4 weeks before the first use of the study drug (ctc ae\>2); baseline chest imaging examination showed active pulmonary inflammation, symptoms and signs of infection within 2 weeks before the first use of the study drug, or the need for oral or intravenous antibiotics； * have a history of interstitial lung disease； * the subjects had active hepatitis b (hbv dna ≥ 2000 iu/ml or 104copies/ml), hepatitis c (hepatitis c antibody positive and hcv-rna higher than the lower limit of the analysis method); * pregnant or lactating women; * there are serious complications or other major diseases that have not been cured; * patients judged by thoracic surgeons to be intolerant of surgery