esophageal squamous cell carcinoma
Conditions
Interventions
Combination group:IMRT: 50.4Gy/28F, 5.5W (D1-D5/ week)
Chemotherapy: Drug and dose determined by the investigator, 21 days for a treatment cycle, 4~6 cycles
Adebrelimab: 20 mg/kg, 21 days in a treatment cycle, intravenous infusion on the first day of each cycle, treatment until disease progression, death, or the emergence of intolerable toxicity, or at le
Sequential group:IMRT: 50.4Gy/28F, 5.5W (D1-D5/ week)
Adbelizumab: 20 mg/kg within 14 to 42 days after the end of concurrent chemoradiotherapy, 21 days as a treatment cycle, intravenous infusion on the first day of each cycle, treatment until disease pro
Sponsors
Jiangsu Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years old, gender unlimited; 2. Patients with small cell lung cancer confirmed by histopathology or cytology; 3. Patients who have previously received limited-stage SCLC (LS-SCLC) treatment must have received radical treatment, and the treatment-free interval between the last chemotherapy, radiotherapy, or radiotherapy cycle and the diagnosis of ES-SCLC should be at least 6 months; 4. Measurable lesions defined by RECIST standard v1.1; 5. Previously treated patients with asymptomatic CNS metastases who met all of the following criteria were eligible to participate in this study: only supratentorial and cerebellar metastases (i.e., no metastases in the midbrain, pontine, medullobulbar, or spinal cord); No need for continuous use of corticosteroids for CNS disease; Imaging studies from the end of targeted CNS treatment to the time of randomization showed no progress. If imaging during the screening period reveals new asymptomatic CNS metastases in the patient, radiation therapy and/or surgery for CNS metastases must be performed. After treatment, these patients did not need to undergo additional brain scans before randomization if they met all other criteria; 6. ECOG: 0 ~ 1; 7. Having adequate organ and bone marrow function, as defined below: Hemoglobin =9.0 g/dL neutrophil absolute count =1.5×109/L Platelet count =100×109/L INR=1.5 Total bilirubin (TBL) =1.5× upper limit of normal (ULN) AST and ALT=2.5×ULN Serum albumin =3.0 g/dL serum creatinine =1.5×ULN or measured creatinine clearance > 60 mL/min or creatinine clearance > 60 mL/min calculated according to the Cockcroft-Gault formula (using actual body weight) : Men: creatinine clearance =(weight x (140- age))/(72 x serum creatinine) Women: Creatinine clearance =(body weight x (140-age))/(72 x serum creatinine)x 0.85, where CL=mL/min; Serum creatinine =mg/dL; 8. Patients with active HBV infection should receive antiviral therapy for more than 2 weeks according to local antiviral treatment guidelines before enrollment, and should continue treatment for 6 months after study drug therapy; 9. A negative hepatitis C virus (HCV) antibody test at screening, or a positive HCV antibody test at screening, and a subsequent negative HCV RNA test; 10. Expected survival =12 weeks; 11. The investigator determined that the patient could receive adebrelimab therapy; 12. Voluntarily participate in this study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Have a high risk of esophageal fistula, such as a history of esophageal fistula or related symptoms, or primary tumor infiltration into large blood vessels or trachea; 2. Evidence of complete esophageal obstruction, not suitable for treatment; 3. Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis (other than diverticulitis), systemic lupus erythematosus, sarcoidosis syndrome or Wegener syndrome [granuloma with polyvasculitis, Graves' disease, rheumatoid arthritis, pituitaritis, uveitis, etc.]). The following are exceptions to this standard: (a) patients with vitiligo or alopecia; (b) Patients with hypothyroidism (e.g., after Hashimoto syndrome) and receiving stable hormone replacement therapy; (c) Any chronic skin disease that does not require systemic treatment; (d) Patients who have not had active disease in the last 5 years may be included, but only after consulting the study physician; (e) Patients with celiac disease who can be controlled by diet alone; 4. Active infections, including tuberculosis (clinical evaluation includes clinical history, physical examination, imaging findings, and TB testing consistent with local treatment principles); 5. Uncontrolled complications, including but not limited to persistent or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, uncontrolled cardiac arrhythmia, active interstitial lung disease, and severe chronic gastrointestinal disease with diarrhea, Or a mental illness/social condition that limits study compliance, significantly increases the risk of developing AE, or impairs the patient's ability to provide written informed consent; 6. The thyroid function has been abnormal in the past, and the thyroid function still cannot be maintained within the normal range under the condition of drug treatment; 7. Current or previous use of an immunosuppressive drug within 14 days prior to first administration of aldebelizumab. The following are exceptions to this standard: (a) intranasal, inhaled, topical or locally injected steroids (e.g., intra-articular injections; (b) systemic glucocorticoids not exceeding the physiological dose equivalent to 10 mg/ day of prednisone or its equivalent; (c) steroid hormones used as a pre-treatment for hypersensitivity reactions (e.g., CT scan pre-treatment); 8. Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders; 9. Known history or evidence of interstitial lung disease or active non-infectious pneumonia; 10. Live attenuated vaccine should be administered within 30 days prior to the first administration of the investigational drug. Note: If enrolled, patients should not receive the live vaccine during treatment with the study drug and within 30 days after the last administration of the study drug; 11. Known allergic or hypersensitive reactions to any investigational drug or to any excipients thereof; 12. Enrolling in another clinical study at the same time, unless the study is an observational (non-interventional) clinical study, or the follow-up period of the interventional study; 13. Other conditions determined by the investigator to be unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-LPFS ; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS ;LPFS;MPFS;OS; | — |
Countries
China
Contacts
Public ContactXinchen Sun
Jiangsu Provincial People's Hospital
Outcome results
None listed