self-financing
Conditions
Interventions
Intervention group:Sintilimab+Anlotinib+Radiotherapy
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent prior to the implementation of any trial-related procedures; 2. Age>=18 years old and 3 months; 12. Adequate organ function, subjects need to meet the following laboratory indicators: (1) In the absence of granulocyte colony-stimulating factor in the past 14 days, the absolute neutrophil value (ANC) was >=1.5x10^9/L; (2) In the case of no blood transfusion in the past 14 days, platelet = 100×109/L; (3) In the absence of blood transfusion or erythropoietin in the past 14 days, hemoglobin > 9g/dL; (4) total bilirubin =60 ml/min; (8) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; 13. Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within normal limits. If the baseline TSH is outside the normal range, subjects may also be enrolled if the total T3 (or FT3) and FT4 are within the normal range; 14. Cardiac enzyme spectrum within the normal range (if the investigator comprehensively judges that it is not clinically significant, simple laboratory abnormalities are also allowed to
Exclusion criteria
Exclusion criteria: 1. The pathology is small cell lung cancer (SCLC), including lung cancer with mixed SCLC and NSCLC; 2. Subjects with cavitary squamous cell carcinoma or imaging suggestive of large vessel invasion/invasion, etc., as assessed by the investigator to have bleeding tendency; 3. Active hemoptysis (coughing up at least 1/2 teaspoon of fresh blood at a time) within 2 weeks prior to the first study drug administration; 4. Received radiation therapy prior to the first dose of study drug, in one of the following conditions: (1) >=30% of bone marrow has received radiotherapy within 14 days prior to treatment (2) Received radiotherapy for lung lesions within 6 weeks prior to treatment at a dose of > 30Gy (enrolled subjects must have recovered from the toxicity of previous radiotherapy to Grade 1 or below, without glucocorticoid therapy and no history of radiation pneumonitis) c) Palliative radiotherapy end time within 7 days prior to the first dose of study drug; 5. Major surgical treatment within 3 weeks of the first study drug administration (except for surgery for the purpose of biopsy); 6. Diagnosis of other malignant diseases other than NSCLC within 5 years prior to the first dose (excluding radically treated basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection); 7. Current participation in interventional clinical study treatment, or treatment with other investigational drugs or investigational devices within 4 weeks prior to the first dose; 8. Prior treatment with the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 agents or another drug that stimulates or synergistically inhibits T cell receptors (e.g., CTLA-4, OX-40, CD137); 9. Received systemic systemic therapy with anti-lung cancer indications of proprietary Chinese medicines or immunomodulatory drugs (including thymic peptides, interferons, interleukins, except for topical use for the control of pleural effusion) within 2 weeks prior to the first dose; 10. Active autoimmune disease requiring systemic therapy (e.g., use of disease-modifying medications, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy; 11. Systemic glucocorticoid therapy (excluding nasal spray) within 7 days prior to the first dose of the study inhaled or other routes of topical glucocorticoids) or any other form of immunosuppressive therapy; Note: Physiologic doses of glucocorticoids (<=10 mg/day of prednisone or equivalent) are allowed 12. Presence of clinically uncontrollable pleural effusion/ascites effusion (patients who do not need to drain the effusion or who stop draining for 3 days without a significant increase in the effusion can be enrolled); 13. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 14. Those who are known to be allergic to the active ingredients or excipients such as sintilimab and anlotinib of this study; 15. Those with a variety of factors that affect oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 16. Patients with bleeding tendencies (such as active peptic ulcers) or treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; Low-dose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Disease control rate;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactChangmin Liu
Anhui Provincial Cancer Hospital
Outcome results
None listed