Esophageal squamous cell carcinoma
Conditions
Interventions
Test Group:Short-course radiotherapy followed by adbelimumab and chemotherapy
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 70 years old, male or female; 2. patients with pathologically confirmed esophageal squamous cell carcinoma (cT1b-cT2N+ or cT3-cT4aNany, thoracic); 3. presence of measurable and/or non-measurable lesions as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1); 4. had received no previous systemic anti-tumor therapy for esophageal cancer; 5. ECOG PS: 0-1; 6. expected survival time >=12 weeks; 7. The functions of vital organs meet the following requirements: a) Routine blood test (in the absence of blood transfusion and hematopoietic stimulating factor drugs within 14 days) : Hemoglobin (Hb) >=90 g/L; Absolute neutrophil count (ANC) >=1.5×10^9 /L; Platelet (PLT) >=100×10^9 /L; White blood cell count (WBC) >=3.0×10^9 /L; b) Biochemical tests: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =50ml/min; c) Coagulation function: Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) =50%; 8. women who are not surgically sterilized or of childbearing age should use a medically approved contraceptive method during the study treatment period and for 3 months after the end of the study treatment period; Women of childbearing age who were not surgically sterilized had to have a negative serum or urine HCG test within 72 h before study entry. And must be non-lactating; For men, surgical sterilization or consent to use an appropriate method of contraception during the trial and for 3 months after the last dose of the trial drug; 9. The patients voluntarily participated in this study, signed the informed consent form (ICF), and the compliance was good.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, or those of childbearing potential who refuse to use contraception; 2. The history of other malignant tumors within the past 5 years, excluding adequately treated cervical carcinoma in situ or cutaneous squamous cell carcinoma, or basically controlled skin basal cell carcinoma; 3. Being treated for any of the following: 1) receiving any investigational drug within 4 weeks before the first dose; 2) subjects requiring systemic treatment with corticosteroids (> 10 mg prednisone equivalent daily) or other immunosuppressive agents within 2 weeks before the first dose of study drug, except for the treatment of local esophageal inflammation, prevention of allergy, nausea, and vomiting. In the absence of active autoimmune disease, inhaled or topical steroids were allowed at doses > 10 mg/ day of prednisone or equivalent corticosteroids; 3) vaccinated with a live vaccine or within 4 weeks before the first dose of study drug; 4. Suffering from hemorrhagic disease or previous history of hemorrhagic disease; 5. Major surgery or major trauma within 4 weeks before the first dose of study drug; 6. Patients with uncontrolled, symptomatic brain metastases or a history of uncontrolled mental illness or severe intellectual or cognitive impairment; 7. History of interstitial lung disease and non-infectious pneumonia; 8. Patients with active pulmonary tuberculosis infection detected by medical history or CT examination, or patients with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or patients with a history of active pulmonary tuberculosis infection before 1 year but without regular treatment; 9. Patients with active autoimmune diseases, history of autoimmune diseases, such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism after thyroid hormone replacement therapy can be included; Patients with vitiligo, cured childhood asthma/allergies without any intervention in adulthood, and type I diabetes with stable doses of insulin were excluded. 10. A history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or a history of organ or allogeneic bone marrow transplantation; 11. The subject has uncontrolled cardiovascular clinical symptoms or diseases, including but not limited to: 1) heart failure in NYHA class II or above; 2) unstable angina pectoris; 3) history of myocardial infarction within 1 year; 4) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 12. Severe active infection requiring intravenous antibiotic treatment within 4 weeks before study drug use; 13. Allergic to the test drug; 14. Patients who are unable to adhere to the trial regimen or to cooperate with follow-up visits; 15. Those who were deemed unsuitable to participate in the trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Major Pathological Response (MPR);Objective Response Rate (ORR);Disease-free SURVIVAL (DFS);Overall Survival (OS);Patient Reported Outcomes (PROs);Safety; | — |
Countries
China
Contacts
Public ContactLi Chen
The First Medical Center of PLA General Hospital
Outcome results
None listed