Esophageal Squamous Cell Carcinoma
Conditions
Interventions
intervention group:Neoadjuvant therapy of low-dose radiotherapy plus targeted immunotherapy
Sponsors
Daping Hospital, Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form and follow the program requirements; 2. Age 18-80 years old, gender is not limited; 3. Physical fitness score ECOG=1); 7. No previous systemic treatment for esophageal squamous cell carcinoma, including drug therapy, radiotherapy, surgical treatment, etc.; 8. Have adequate organ and bone marrow function, and the laboratory tests performed for screening must meet the following criteria: Bone marrow: absolute neutrophil count (ANC) >=1.5×10^9/L, platelet count >=100×10^9/L, hemoglobin >=90 g/L, and no blood transfusion or biological response modifiers (such as granulocytes, erythrocyte growth factor, etc.) therapy within 14 days before the first dose; Liver: Total bilirubin (TBIL)=30 g/L; Kidney: creatinine clearance (Ccr) >=50 mL/min (according to the Cockcroft and Gault formula); Coagulation function: International normalized ratio (INR) =50%; 9. Males of childbearing potential and females of childbearing age are willing to take effective contraceptive measures from signing the informed consent form to 6 months after the last dose of the trial drug; Women of childbearing age include premenopausal women and women within 2 years of postmenopause. Women of childbearing age must have a negative blood pregnancy test result within 7 days before the first dose of trial drug.
Exclusion criteria
Exclusion criteria: 1. Voluntarily sign the informed consent form and follow the program requirements; 2. Age 18-80 years old, gender is not limited; 3. Physical fitness score ECOG=1+); 7. No previous systemic treatment for esophageal squamous cell carcinoma, including drug therapy, radiotherapy, surgical treatment, etc.; 8. Have adequate organ and bone marrow function, and the laboratory tests performed for screening must meet the following criteria: Bone marrow: absolute neutrophil count (ANC) >=1.5×10^9/L, platelet count >=100×10^9/L, hemoglobin >=90 g/L, and no blood transfusion or biological response modifiers (such as granulocytes, erythrocyte growth factor, etc.) therapy within 14 days before the first dose; Liver: Total bilirubin (TBIL)=30 g/L; Kidney: creatinine clearance (Ccr) >=50 mL/min (according to the Cockcroft and Gault formula); Coagulation function: International normalized ratio (INR) =50%; 9. Males of childbearing potential and females of childbearing age are willing to take effective contraceptive measures from signing the informed consent form to 6 months after the last dose of the trial drug; Women of childbearing age include premenopausal women and women within 2 years of postmenopause. Women of childbearing age must have a negative blood pregnancy test result within 7 days before the first dose of trial drug. This answer is AI-generated and is for informational purposes only, please screen carefully. 1) History of other primary malignancies within the past 3 years, except for completely radical resected basal cell carcinoma of the skin, superficial bladder cancer, cutaneous squamous cell carcinoma or cervical cancer in situ; 2) Presence of peripheral neuropathy = grade 2 (according to CTCAE v5.0); 3) Received any of the following treatments: ? Received intravenous antibiotic therapy within 7 days before the first dose; ? Investigational drugs that have received other clinical trials within 4 weeks before the first dose; ? Receipt of live attenuated vaccines within 4 weeks prior to the first dose, inactivated seasonal influenza vaccines or approved COVID-19 vaccines without live virus are allowed; ? Received systemic immunostimulatory drugs (including but not limited to interferon, interleukin-2, etc.) within 4 weeks before the first dose; ? Received major surgical treatment (such as transabdominal, thoracic, etc., excluding diagnostic puncture, infusion device implantation, gastrointestinal stent implantation, etc.), or expected to require major surgical treatment other than tumor during the study neoadjuvant therapy; ? Previous immunotherapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies (including ipilimumab) or any other antibody or drug targeting T cell co-stimulation or immune
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response, pCR;Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response, MPR;Disease-Free Survival, DFS;Event-Free Survival, EFS;Overall Survival, OS;Surgical Completion Rate;R0 Resection Rate;Safety; | — |
Countries
China
Contacts
Public ContactMengxia Li
Daping Hospital, Army Medical University
Outcome results
None listed