Non-small Cell Lung Cancer
Conditions
Interventions
experimental group:PD-1 inhibitor in combination with anlotinib neoadjuvant therapy
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. Patients with histologically confirmed clinical stage II and stage III non-small cell lung cancer (requiring biopsy); 3. At least one repeatable tumor lesion (according to RECIST 1.1 criteria); 4. ECOG score data 0-1; 5. Subjects with good organ function: (1) WBC >= 2000 / mm3; (2) Absolute neutrophil count (ANC) >= 1000 / mm3; (3) Platelet count >= 100000 / mm3; (4) Hemoglobin >= 9g / dl; (5) Creatinine = 92% at rest and walking (no oxygen inhalation). 6. Patients with an estimated survival time of 12 weeks or more; 7. The patients who voluntarily joined the study signed the informed consent form (ICF) with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with central or cavitary non-small cell lung cancer; 2. Patients who are at risk of massive hemoptysis or have bloody sputum; 3. Patients with active, known or suspected autoimmune diseases. Subjects with vitiligo, type I diabetes, residual hypothyroidism requiring only hormone replacement due to autoimmune thyroiditis, or disease that is not expected to recur without an external trigger were allowed to register. Systemic treatment with corticosteroids (> 10 mg prednisone equivalent per day) or other immunosuppressive drugs is required within 14 days after the first administration. In the absence of active autoimmune disease, inhaled or topical steroid and adrenal replacement steroid doses are permitted; 4. Patients who use chemotherapy or any other cancer therapy during the preoperative period; 5. Patients with active concurrent malignancies were excluded, i.e. cancers other than NSCLC (except non melanoma skin cancer, bladder cancer in situ, gastric cancer, breast cancer, colon cancer or cervical cancer / dysplasia); 6. Patients with brain metastases were excluded from this study, and all patients should have brain imaging (enhanced MRI or CT brain imaging) before inclusion; 7. Patients with history of interstitial lung disease; 8. Positive detection of hepatitis B surface antigen or hepatitis C RNA in patients with active systemic infection requiring treatment; 9. Patients with a history of allergy to the components of the study drug; 10. Pregnant or lactating women; 11. Patients previously treated with anti-PD-1, anti-PD-L1, anti-pdl-2 or anti-CTLA-4 antibodies (or any other antibodies targeting T cell co regulatory pathways); 12. The researchers believe that under the existing medical conditions, the use of research drugs may make the subject dangerous or obscure the explanation of toxicity or adverse events; 13. Patients with central tumor whose distance from tumor focus to large blood vessel was less than or equal to 5 mm, or with local large blood vessel invasion, or with obvious cavitary / necrotic tumor in lung; 14. Patients with abnormal coagulation function (INR > 1.5 x ULN, APTT > 1.5 x ULN) have bleeding tendency or are receiving thrombolytic, anticoagulant or antiplatelet therapy, including obvious hemoptysis / hemoptysis of two teaspoons or more per day within 2 months, significant clinical bleeding symptoms or definite bleeding tendency within 3 months, The occurrence of arteriovenous thrombosis within 12 months or other known hereditary or acquired bleeding and thrombotic tendency; 15. Patients with hypertension who can not be reduced to normal range after antihypertensive drug treatment (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 16. Patients with long-term unhealed wounds / fractures; 17. Patients with cardiovascular diseases above grade II or poorly controlled; 18. Patients with small cell lung cancer (including small cell lung cancer and non-small cell lung cancer).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| main pathological remission, MPR;Event of peri-operative adverse effects;Surgical feasibility rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Nodal Downstaging at Surgery;Disease-Free Survival; | — |
Countries
China
Contacts
Public ContactXu Song
Tianjin Medical University General Hospital
Outcome results
None listed