esophagus cancer
Conditions
Interventions
Single arm group:Preoperative immunotherapy: Karelizumab+preoperative chemotherapy: Albumin paclitaxel, carboplatin+preoperative radiotherapy+surgery
Sponsors
Affiliated Cancer Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 73 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 ~ 73 years old, male or female; 2. Pathological diagnosis of resectable thoracic esophageal squamous cell carcinoma (cT1b-cT2N + or cT3-cT4a, any N); 3. At least one measurable lesion (according to RECIST 1.1 version, the length and diameter of spiral CT scan for measurable esophageal lesions were =10 mm, the short diameter of CT scan for lymph node lesions were =15 mm, and the thickness of the scan layer was no more than 5 mm; And have not received local treatment), and measurable lesions suitable for surgery; 4. Expected survival =6 months; 5.ECOG score 0-1; 6. Major organs function well, that is, relevant examination indicators within 1 week before enrollment meet the following requirements: Blood routine examination: a. Hemoglobin content (HB) =90g/L (no blood transfusion within 28 days); b. Absolute neutrophil count (ANC) =1.5×10^9/L; c. Platelet count (PLT) =100×10^9/L; Biochemical examination: a. Serum total bilirubin (TBIL) =1.5 times the upper limit of normal value (ULN); b. Serum glutamic-pyruvic transaminase (ALT) and serum glutamic-oxalacetic transaminase (AST) =2×ULN; c. Plasma Cr=1.5×ULN; 7. Cardiac Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) = 50%; 8. Women of childbearing age were required to undergo a negative pregnancy test (blood/urine) within 1 week prior to enrollment and to voluntarily use an appropriate method of contraception during the observation period and for 6 months after the last study drug administration; For males, they should be surgically sterilized or agree to use an appropriate method of contraception during the observation period and within 6 months after the last study drug administration; 9. No prior anti-tumor therapy, including surgery, chemotherapy, radiotherapy and targeted therapy; The subjects voluntarily joined the study, signed the informed consent, complied well, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Unable to tolerate digestive endoscopic biopsy; 2. Have clear concerns about gastrointestinal bleeding (e.g. locally active ulcerative lesions, positive fecal occult blood); History of gastrointestinal bleeding within 6 months; 3. Had other active malignancies within 5 years prior to study entry. Basal cell or squamous cell carcinoma of the skin, superficial bladder carcinoma, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma that can be treated locally are excluded; 4. Received the following treatments or medications prior to the initial study therapy: a. Major surgery within 28 days prior to the initial study therapy (tissue biopsy required for diagnosis is permitted); b. Live attenuated vaccine received within 28 days prior to the initial study drug treatment or planned during the study period and within 60 days after the end of study drug treatment; c. Receiving antitumor therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biotherapy or tumor embolization) within 28 days prior to the initial study drug therapy; 5. Present with any active autoimmune disease or history of autoimmune disease with expected recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects controllable by hormone replacement therapy alone can be included]; Subjects with skin diseases that require no systemic treatment, such as vitiligo, psoriasis, alopecia, type I diabetes, or asthma that has been completely resolved in childhood and can be included as adults without any intervention; Patients with asthma requiring medical intervention with bronchodilators are not included); 6. Pregnant or lactating women; 7. Patients with myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or above cardiac dysfunction, or clinically significant suprachiventricular or ventricular arrhythmias requiring clinical intervention during the 6 months prior to study entry; 8. Systemic antibiotic use = 7 days within 4 weeks prior to the first dose, or unexplained fever >38.5°C during the screening period/prior to the first dose (as determined by the investigator, tumor-related fever could be included); 9. Central nervous system metastasis has occurred; 10. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 11. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B, defined as positive HBV surface antigen [HBsAg] test, HBV-DNA = 500 IU/ml, and abnormal liver function; Hepatitis C, defined as hepatitis C antibody [HCV-Ab] positive, HCV-RNA above the lower detection limit of analytical methods and abnormal liver function) or co-infection with hepatitis B and hepatitis C; 12. Participated in any other drug clinical studies within 4 weeks prior to the initial administration; 13. A clear history of neurological or psychiatric disorders, including epilepsy and dementia; A known history of psychotropic substance abuse, alcohol or drug abuse; 14. Known allergy to the study drug or any excipients thereof; Or have had a severe allergic reaction to other monoclonal antibodies; The study was not considered suitable for patients enrolled in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival; | — |
Countries
China
Contacts
Public ContactHuang Wei
Affiliated Cancer Hospital of Shandong First Medical University
Outcome results
None listed