Sequential Preoperative Penpulimab Combined With Chemoradiotherapy(CRT) for Locally Advanced Esophageal Squamous Cell Cancer

Sequential Preoperative Penpulimab Combined With Chemoradiotherapy(CRT) for Locally Advanced Esophageal Squamous Cell Cancer: A Prospective, Single Arm, Single Center，Exploratory Study

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).

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