NSCLC
Conditions
Interventions
Experimental Group:Chemoradiotherapy/radiotherapy followed by camrelizumab and apatinib maintenance therapy
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old; 2. Confirmed with stage III NSCLC by histology and imaging (according to the 8th edition of AJCC); 3. Patients without surgical indications after chemoimmune induction therapy (including but not limited to patients who actively refuse surgery and SD or PD assessed by imaging), and the severity of immune-related adverse reactions during chemoimmune therapy is = 1.5×10^9/L, platelet count >= 100×10^9/L, hemoglobin >= 90g/L [No blood transfusion or erythropoietin dependence within 7 days]; 10. Good liver function, defined as total bilirubin level = 60 ml/min (Cockcroft-Gault formula); urine routine examination urine protein less than 2+, if the patient has a baseline urine protein level >= 2+, a 24-hour urine collection should be performed and the 24-hour urine protein quantitative test should be proved to be <= 1g; 12. Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; if the subject is receiving anticoagulant therapy, as long as the PT is within the intended use range of the anticoagulant; 13. For female subjects of childbearing potential, a serum pregnancy test should be performed within seven days before the first dose of the trial drug (1st cycle, 1st day), and the result should be negative; 14. The subject must agree to use effective contraceptive methods or be surgically sterilized during the trial and within 90 days after the last dose of the trial drug; 15. Able to comply with the research and follow-up procedures; 16. Sign a written informed consent before any trial-related procedures are implemented.
Exclusion criteria
Exclusion criteria: 1. Toxicity that has not been resolved by previous chemoimmunotherapy, CTCAE > 3 grade; 2. Imaging (CT or MRI) shows that the tumor invades large blood vessels or has unclear boundaries with blood vessels, and a single hemoptysis volume of >= 2.5mL within 1 month before the first medication; 3. Active bleeding or perforation or hereditary or acquired bleeding tendency; 4. Hypertension that cannot be reduced to normal range after antihypertensive drug treatment (systolic blood pressure = 300 mg/day or clopidogrel >= 75 mg/day) 7. Evidence of severe or uncontrolled systemic disease, including active bleeding diabetes or active infection, including hepatitis B, hepatitis C, and HIV; 8. Evidence of uncontrolled disease, such as symptomatic congestive heart failure, uncontrolled hypertension, or unstable angina; 9. Active or previously documented inflammatory bowel disease (such as Crohn's disease, ulcerative colitis); 10. Subjects who have had a serious infection within 4 weeks before the first dose, including but not limited to requiring hospitalization Infectious complications, bacteremia, severe pneumonia, etc.; subjects with any active infection are excluded; lymphatic spread of lung cancer is not excluded; 11. Pregnant and lactating women; 12. Known allergy to carrelizumab injection, apatinib mesylate tablets or any of their excipients; 13. Suffering from malignant tumors other than NSCLC within 5 years before enrollment, excluding fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery. 14.Except for alopecia and fatigue, other toxicities caused by previous anti-tumor treatment need to be restored to CTCAE 5.0<= 1 before the first dose of study drug. Other toxicities caused by previous anti-tumor treatment that cannot be resolved within the expected period and have long-term sequelae, such as neurotoxicity caused by platinum-based treatment, are allowed to be enrolled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events were evaluated using NCI CTCAE version 5.0.;Progression-free survival;Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Countries
China
Contacts
Public ContactYongchun Song
Tianjin Medical University Cancer Institute and Hospital
Outcome results
None listed