Phase
Condition
Lung Cancer
Esophageal Disorders
Squamous Cell Carcinoma
Treatment
N/AClinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
A histopathological diagnosis of resectable thoracic esophageal squamous cellcarcinoma with a pre-treatment clinical stage of T1-4aN1-3M0 or T3-4aN0M0 according tothe 8th edition of the UICC staging system;
Patients who are anti-tumor treatment-naive;
Estimated life expectancy >6 months
Aged 18 to 70 years old of either gender
The function of important organs meets the following requirements: a. white blood cellcount (WBC) ≥ 4.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L; b. platelets ≥ 100×109/L; c. hemoglobin ≥ 9g/dL; d. serum albumin ≥ 2.8g/dL; e. total bilirubin ≤ 1.5×ULN, ALT, AST and/or AKP ≤ 2.5×ULN; f. serum creatinine ≤ 1.5×ULN or creatinineclearance rate >60 mL/min;
PS score of 0-1;
Ability to understand the study and sign informed consent.
Exclusion
Exclusion Criteria:
Patients who have been treated previously with anti-tumor therapy (includingchemotherapy, radiotherapy, surgery, immunotherapy, etc.);
Known or suspected allergy or hypersensitivity to monoclonal antibodies, anyingredients of Toripalimab, and the chemotherapeutic drugs paclitaxel or cisplatin;
Patients who have a preexisting or coexisting bleeding disorder;
Other uncontrollable inoperable patients;
Female patients who are pregnant or lactating;
Inability to provide informed consent due to psychological, familial, social and otherfactors;
Presence of CTC grade ≥ 3 peripheral neuropathy;
A history of malignancies other than esophageal cancer before enrollment, excludingnon-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer
A history of diabetes for more than 10 years and poorly controlled blood glucoselevels;
Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung,liver or kidney dysfunction, or hematopoietic disease or cachexia.
Active autoimmune diseases, a history of autoimmune diseases (including but notlimited to these diseases or syndromes, such as colitis, hepatitis, hyperthyroidism),a history of immunodeficiency (including a positive HIV test result), or otheracquired or congenital immunodeficiency diseases, a history of organ transplantationor allogeneic bone marrow transplantation;
A history of interstitial lung disease or non-infectious pneumonia;
A history of active pulmonary tuberculosis infection within 1 year or a history ofactive pulmonary tuberculosis infection more than 1 year ago but without formalanti-tuberculosis treatment;
Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit ofthe assay).
Study Design
Connect with a study center
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510060
ChinaActive - Recruiting

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