Lung cancer and esophageal cancer
Conditions
Interventions
Lung cancer group:Radiotherapy (choice of radiation field and dose of radiation to be determined by the investigator) + chemotherapy (3-6 cycles, to be determined by the investigator) + karelizumab (2
Esophageal Cancer Group:Radiotherapy (choice of radiation field and dose of radiation to be determined by the investigator) + chemotherapy (3-6 cycles, to be determined by the investigator) + karelizu
Sponsors
Jiangsu Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged = 18 years; 2. Understand the steps and contents of the study and voluntarily sign the written informed consent; 3. Advanced lung and esophageal cancer with multiple lymph node metastases confirmed by pathological histology and cytology; 4. At least one measurable lesion in the radiation field (assessed by the investigator based on RECIST v1.1); 5. Physical status score (ECOG PS score): 0-1; 6. Expected survival = 3 months; 7. Good function of major organs, i.e., the following requirements for relevant tests within 14 days before enrollment: erythrocyte protein = 90 g/L (no blood transfusion within 14 days); neutrophil count > 1.5 × 109/L; platelet count = 100 × 109/L; total bilirubin = 1.5 × ULN (upper limit of normal); blood alanine aminotransferase (ALT) or blood glutamic acid transaminase (AST) = 2.5 × ULN; if any, the total bilirubin = 2.5 × ULN; and the blood glutamic acid transaminase = 1.5 × ULN (upper limit of normal). 2.5 × ULN; ALT or AST = 5 × ULN if liver metastases are present; endogenous creatinine clearance = 60 mL/min (Cockcroft-Gault formula); and left ventricular ejection fraction (LVEF) = 50% by cardiac Doppler ultrasound; 8. The investigator determines that the patient is amenable to treatment with karelizumab; 9. Voluntarily participate in this study by signing an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects with a prior history of other malignancies, except for carcinoma in situ that has achieved complete remission at least 5 years prior to screening and does not require or is not expected to require other treatment during the study period; 2. Subjects with known or suspected interstitial pneumonitis, other moderate-to-severe lung disease that may interfere with the detection or management of drug-related pulmonary toxicity and that severely affects respiratory function. This includes idiopathic pulmonary tissue fibrosis, organic pneumonia/occlusive fine bronchitis, etc; 3. Subjects with severe cardiovascular disease, such as conditions that meet NYHA criteria (Class III or higher) or myocardial infarction or cerebrovascular accident (cerebral ischemia, symptomatic cerebral infarction, etc.) or concomitant coronary artery disease with unstable arrhythmia or unstable angina occurring within 1 month prior to the first dose of drug, or congestive Heart failure or screening left ventricular ejection fraction < 50% or pre-existing symptomatic superior vena cava syndrome; 4. Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study; 5. History of live attenuated vaccination within 28 days prior to the first study dose or anticipated live attenuated vaccination during the study period; 6. Subjects with active Hepatitis B (defined as a positive Hepatitis B Virus Surface Antigen [HBsAg] test result at Screening with a concomitant HBV-DNA test value of = 2000 IU/ML) or Hepatitis C (defined as a positive Hepatitis C Virus Surface Antibody [HCsAb] test result at Screening with a positive HVC-RNA test result); 7. Serious infection within 4 weeks prior to the first dose, including but not limited to complications of infection requiring hospitalization or = 2 weeks of intravenous antibiotic administration therapy, bacteremia, and severe pneumonia; 8. Have experienced clinically significant bleeding symptoms or have a significant bleeding tendency within 1 month prior to screening, e.g., gastrointestinal bleeding, bleeding from gastric ulcers, or have vasculitis 9. Have multiple factors that interfere with oral administration of medications (e.g., inability to swallow, chronic diarrhea, and bowel obstruction) 10. Uncontrollable moderate to large pleural effusions requiring repeated drainage, abdominal effusions or pericardial effusions 11. History of severe allergic reactions to other monoclonal antibodies/fusion proteins; 12. A subject's known history of psychotropic substance abuse, alcoholism, or drug addiction 13. Any other medical (e.g., pulmonary, metabolic, endocrine, or neurological disease, congenital disease, etc.), psychiatric, or social condition that, in the opinion of the Investigator, may interfere with the subject's rights, safety, health, or ability to sign informed consent, to cooperate and participate in the study, or with the evaluation of the investigational medication, the interpretation of the safety of the subject, or the results of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Progression-Free-Survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactDANMING LI
Jiangsu Provincial People's Hospital
Outcome results
None listed