Locally advanced esophageal carcinoma
Conditions
Interventions
experimental group:islelizumab combined with neoadjuvant chemotherapy
Sponsors
Peking Union Medical College Hospital; Baiji Shenzhou (Shanghai) Biomedical Technology Co., Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) Be able to provide written informed consent and understand and agree to follow the research requirements and evaluation schedule; 2) At the time of signing the informed consent form, the age was >= 18 years old; 3) Pathological (histological) diagnosis of esophageal thoracic squamous cell carcinoma; 4) According to AJCC 8th Edition, ct1-2n1-2m0, T2-4 anynm0 at the initial diagnosis; 5) The patients were suitable and agreed to receive neoadjuvant chemotherapy combined with surgery; 6) According to RECIST version 1.1, there were measurable or evaluable lesions; 7) ECoG physical condition = 1.5 x 10^9 / L; white blood cell count (WBC) >= 1.5 x 10^9 / L b) Platelet count (PLT) >= 90 x 10^9 / L c) Hemoglobin (Hgb) >= 90 g / L Note: patients should not receive blood transfusion or growth factor support because neutrophil count, platelet or hemoglobin are lower than the research requirements within 14 days before blood sample collection. d) Renal function requirements within 4 weeks before treatment: endogenous creatinine clearance rate was greater than or equal to 60 ml / min (according to 24-hour urine creatinine calculation or Cockcroft Gault formula). e) Serum total bilirubin 45 years of age without other biological or physiological causes. In addition, in order to confirm menopause, serum follicle stimulating hormone (FSH) levels in women under 55 years of age must be > 40 mIU / ml. 11) Male subjects who were not sterilized should be willing to take effective contraceptive measures during the study period and within 60 days after the last study treatment (including chemotherapy). Research design and methodology.
Exclusion criteria
Exclusion criteria: Patients who met any of the following criteria must be excluded from this study: 1) It is not suitable to receive any dual drug chemotherapy specified in the protocol; 2) Have received any treatment for esophageal squamous cell carcinoma in the past; 3) Patients with evidence of fistula (esophagus / bronchus or esophagus / aorta); 4) Esophageal cancer with distant metastasis; 5) There is evidence of complete esophageal obstruction unsuitable for treatment; 6) That is, they have received PD-1, PD-L1 or PD-L2 targeted therapy in the past 7) Patients with active autoimmune disease or history of autoimmune disease but may relapse. Note: Patients with the following diseases are not excluded and can be further screened: a) Controlled type 1 diabetes; b) Hypothyroidism (if controlled by hormone replacement therapy alone); c) Controlled celiac disease; d) Skin diseases without systemic treatment (e.g. vitiligo, psoriasis, alopecia); e) Any other disease that is not expected to recur without an external trigger; 8) There are any active malignancies within 2 years before treatment, except for the specific cancers under study in this study and locally recurrent cancers that have been cured (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, cervical cancer in situ or breast cancer). 9) Any condition requiring systemic corticosteroid therapy (prednisone with a dose higher than 10 mg / day or equivalent dose of similar drugs) or other immunosuppressants within 14 days before treatment. Note: patients who have currently or previously used any of the following steroid regimens can be enrolled: a) Adrenaline replacement steroids (prednisone = 160 mmHg or diastolic blood pressure >= 100 mmHg even though antihypertensive drugs were used within <= 28 days before treatment or the first administration of study drug h) An
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Index complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Main pathological remission rate;Objective remission rate;Event free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactChunmei Bai
Peking Union Medical College Hospital
Outcome results
None listed