esophagus cancer
Conditions
Interventions
Experimental group:Postoperative Toripalimab therapy
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Male and Female aged 18 years or older; 2) Stage ? or ? (according to AJCC 8th Edition) esophageal carcinoma with histological evidence of primarily squamous cell carcinoma at initial diagnosis; 3) Subjects must complete preoperative (neoadjuvant) chemotherapy before grouping and receive surgery afterwards. Platinum-containing chemotherapy should be used. Chemotherapy regimens should be in accordance with NCCN or ESMO guidelines and with local standards Treatment; 4) Subjects must undergo complete excision (R0), be determined to be free of disease and have a negative margin on the excised sampledefined as no active tumor within 1mm of the proximal, distal, or surrounding excision margin; 5) The subject must have residual pathological disease, regardless of whether the primary tumor was pCR or not, but ypN+ was reported in the pathology of lymph node resection. The investigator must review the surgical pathology report, confirm malignancy, and sign and date it before grouping; 6) Complete resection must be performed within a time window of 4 to 6 weeks before grouping; 7)ECOG physical status score is 0 or 1; 8) All subjects must be confirmed to be disease-free by thorough physical examination and imaging studies prior to grouping. Imaging studies must include chest and abdominal CT scans; 9) Tumor tissue from the site of disease resection must be provided for biomarker analysis. Subjects must have PD-L1 status results. If the amount of tumor tissue provided for analysis is insufficient, additional archived tumor tissue (tissue blocks and/or sections) should be obtained for biomarker analysis; 10) All baseline laboratory test evaluations will be performed as required and results should be available within 14 days prior to grouping. The selection of laboratory test values must meet the following criteria (using CTCAEv5). WBC>2000/µL; Neutrophil =1500/µL; Platelet =100x103/µL; Hemoglobin =9.0g/dL; Creatinine: serum creatinine =1.5x upper limit of normal (ULN) or creatinine clearance >50mL/ min (using the Cockcroft/Gault formula); AST=3xULN, ALT=3 xULN; Total bilirubin =1.5xULN(except subjects with Gilbert syndrome, where total bilirubin must be <3xULN) 11) The subjects voluntarily joined the study, signed the written informed consent, had good compliance, and cooperated with follow-up; 12) Subjects must be willing and able to comply with planned visits, treatment plans, laboratory tests, tumor biopsies, and other research requirements; 13) Subject re-recruitment; The study allowed re-recruitment of subjects who had not received treatment. If re-recruitment takes place, subjects must give informed consent again; 14) Fertile female subjects must have had a urine or serum pregnancy test negative within 7 days prior to enrollment and be willing to use effective birth control during the study period and for at least 6 months after the last dosing (Toripalimab); Male subjects whose partners were women of childbearing age had to consent to effective birth control during the study period and for at least six months after the last dosing.
Exclusion criteria
Exclusion criteria: 1) Subjects with cervical esophageal cancer. Tumor location issues related to study eligibility may be discussed with researchers at Peking University Cancer Hospital; 2) Subjects who did not receive neoadjuvant chemotherapy before surgery; 3) Subjects with resectable disease staging M1; 4) Complete resection followed by treatment specific to the excised esophageal cancer (e.g. chemotherapy, targeted drugs, radiotherapy or biotherapy) 5) Exclude subjects with previous malignancies unless complete elimination has been achieved at least 5 years prior to study entry and no additional treatment is required or expected to be required during the study period (exceptions include, but are not limited to, basal or squamous cell skin cancers, superficial bladder cancers, or cancers in situ of the prostate, cervix, or breast); 6) Subjects with known or suspected active autoimmune diseases. Subjects are admitted for type I diabetes, hypothyroidism requiring hormone replacement therapy only, skin conditions that do not require systemic treatment (e.g., epilepsy, psoriasis, or hair loss), or conditions that are not expected to recur in the absence of external triggers 7) Subjects with conditions requiring systemic treatment with corticosteroids (>10mg daily prednisone or equivalent) or other immunosuppressive agents within 14 days prior to study drug administration. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal substitute steroids at a daily equivalent dose of >10mg prednisone; 8) Subjects with interstitial lung disease that has symptoms or may interfere with suspected drug-related pulmonary toxicity detection or treatment 9) Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA4 antibodies or any other antibodies or drugs that specifically target T cell costimulation or checkpoint pathways; 10) All toxicities attributable to previous anticancer therapy (other than nephropathy, neuropathy, hearing loss, hair loss, and fatigue) must be restored to Grade 1 (NCI CTCAE 4th Edition) or baseline prior to administration of the study drug. Subjects with toxicity that is attributable to prior anticancer therapy, is not expected to be alleviated, and leads to lasting sequelae (e.g., peripheral neuropathy that occurs after platinum-based therapy) are admitted to the study. Peripheral neuropathy must be remitted to grade 2 (NCICTCAE 5th Edition); 11) Any serious or uncontrolled medical condition or active infection that, in the opinion of the investigator, may increase study participation, risks associated with study drug administration, or impair the subject's ability to receive treatment under the study protocol; 12) Known human immunodeficiency virus (HIV) testing history or known acquired immunodeficiency syndrome (AIDS); 13) Subjects who received live/attenuated vaccine within 30 days of initial treatment; 14) Patients with active viral hepatitis B and C. People infected with acute or chronic active hepatitis B or hepatitis C, hepatitis B virus (HBV)DNA>2000IU/ml or 104 copies /ml; Hepatitis C virus (HCV)RNA>103 copies /ml Hepatitis B surface antigen (HbsAg) and anti-HCV antibody positive; 15) A history of allergic or hypersensitive reactions to study drug ingredients, and a history of severe hypersensitive reactions to any monoclonal antibody; 16) Prisoners or subjects held in involuntary confinement; 17) The subject has participated in other intervention studies; 18) Subj
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| survival rate;DMFS;safety; | — |
Countries
China
Contacts
Public ContactDailiang
Beijing Cancer Hospital
Outcome results
None listed