Non-small cell lung cancer
Conditions
Interventions
PD-1 antibody (PD-L1=50% and with contraindications to Bevacizumab):Neoadjuvant therapy stage: Sintilimab antibody 200mg, q3w, 3 weeks per cycle, 2-4 cycles, then receive chest CT evaluation.
Surgica
PD-1 antibody + Bevacizumab (PD-L1 =1% and without contraindications to Bevacizumab):Neoadjuvant therapy stage: sintilimab 200mg, q3w, 3 weeks per cycle, 2-4 cycles
bevacizumab, 3 weeks per cycle, 2-4 cycles, then receive chest CT evaluation.
Surgical treatment stage: the patients who have a response to targeting therapy (CR+PR) and the patients who have no resp
PD-1 antibody + chemotherapy (PD-L1 PD-L1 = 1% and with contraindications to Bevacizumab):Neoadjuvant therapy stage: PD-1 antibody 200mg, q3w, 3 weeks per cycle, 2-4 cycles
Platinum-based chemotherapy (squamous: carboplatin AUC5, paclitaxel 200mg/m2 or gemcitabine 1000mg/m2
non-squamous: carboplatin AUC5, pemetrexed 500mg/m2), 3 weeks per cycle, 2
Sponsors
Department of Thoracic Surgery, Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Patients with NSCLC confirmed by needle biopsy or bronchoscopy biopsy; 2. Chest CT, PET-CT or / and EBUS were identified as stage III patients (TNM stage 8); 3. Patients without systemic metastasis (MRI, bone scan, PET-CT, liver and adrenal CT, etc.); 4. Patients over 18 years old; 5. Patients with at least one measurable tumor focus (the longest diameter measured by CT > 10 mm); 6. Patients with good function of other main organs (liver, kidney, blood system, etc.): (1) hemoglobin = 90 g/L (can be maintained or exceeded by blood transfusion); (2) RBC count = 2.0 x 10^12/L; (3) neutrophil absolute count (ANC) = 1.0 x 10^9/L; (4) platelet count = 100 x 10^9/L; (5) total bilirubin = 1.5 times the upper limit of normal value; (6) alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase = 2.5 times the upper limit of normal value; (7) creatinine = 1.5 times the upper limit of normal value, and creatinine clearance rate = 60ml / min; (8) the international standard ratio of prothrombin time (INR) < 1.5R and partial thromboplastin time (APTT) < 1.5 times the upper limit of normal value in patients who have not received anticoagulant treatment. Patients receiving full dose or parenteral anticoagulant therapy can enter the clinical trial as long as the dosage of anticoagulant is stable for at least 2 weeks before entering the clinical study, and the results of coagulation test are within the limits of local treatment; 7. Patients with ECoG PS score of 0-1; 8. Patients who are expected to undergo radical surgery; 9. Patients with good lung function and tolerance to surgical treatment; 10. Pregnant women of childbearing age must conduct pregnancy test within 7 days before treatment and the result is negative; reliable contraceptive measures (such as IUD, contraceptive pill and condom) should be used within 30 days before the start and end of the test; male subjects of childbearing age should use condom for contraception within 30 days after the start and end of the test; 11. Patients willing to sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Adenocarcinoma with EGFR mutation or ALK rearrangement; 2. Participants who have received any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment; 3. Administration of any Chinese medicine against cancer before administration of the drug; 4. Participants with cancer other than NSCLC (excluding cervical carcinoma in situ, cured basal cell carcinoma, bladder epithelial tumor [including TA and tis]) within five years before the start of this study; 5. Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (= NYHA Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases; 6. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment; 7. Antibiotics were used to treat the infection for 4 weeks prior to the start of the trial; 8. Participants who were systemically treated with corticosteroids (prednisone or other corticosteroids >10 mg/ day) or other immunosuppressive agents within 2 weeks prior to first administration. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy with a dose of less than 10 mg/ day of prednisone are permitted; 9. Participants who have a history or is currently suffering from nephrotic syndrome; 10. Participants who have a history or is currently suffering from bronchiectasis; 11. Participants who are allergic to the test drug or any auxiliary materials 12. Participants who have a history or is currently suffering from interstitial lung disease; 13. Participants with active hepatitis B, hepatitis C or HIV; 14. The vaccine was administered within 4 weeks of the start of the trial; 15. Participants who have undergone major surgery or severe trauma in other systems within 2 months before the start of this trial; 16. Pleural effusion, pericardial effusion or ascites that are not clinically controlled and require pleural puncture or abdominal puncture drainage within 2 weeks before inclusion; 17. Pregnant or lactating women; 18. Participants suffering from nervous system diseases or mental diseases that cannot cooperate; 19. Participated in another therapeutic clinical study; 20. Other factors that researchers think it is not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major pathologic response (MPR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Obeject response rate (ORR);2-year overall survival (2-y OS);event-free survival (EFS);overall survival (OS);conversion rate of surgery; | — |
Countries
China
Contacts
Public ContactPeng Zhang
Department of Thoracic Surgery, Shanghai Pulmonary Hospital Tongji, University
Outcome results
None listed