Lung cancer
Conditions
Interventions
The test group:Camrelizumab combined with apatinib
Control group:Camrelizumab in combination with chemotherapy
Sponsors
Tianjin Medical University Cancer Institute & Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up; 2. At the time of signing the informed consent, the age is >=18 years old and =1.5L, or FEV1>=800ml after lobectomy/pneumonectomy; (2) Blood routine test standards (no blood transfusion within 14 days) and blood products, not corrected with G-CSF and other hematopoietic stimulating factors); 1) Hemoglobin (HB) >= 90g/L; 2) Absolute neutrophil value (ANC) >= 1.5*10^9/L; 3) Platelet (PLT) >=80*10^9/L; (3) Biochemical tests should meet the following indicators: 1) Total bilirubin (TBIL) =60ml/min. 15. In patients who have not received anticoagulation therapy, the international normalized ratio (INR) of prothrombin time is less than or equal to 1.5, and the partial thromboplastin time (APTT) is less than or equal to 1.5 times the upper limit of normal. Patients receiving full-dose or parenteral anticoagulant therapy can enter clinical trials as long as the dose of anticoagulant drugs is stable for at least 2 weeks before entering the clinical study, and the results of the coagulation test are within the limits of local treatment; 16. Females of childbearing age (15-49 years old) should agree to use contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; within 1 week before study enrollment Negative serum or urine pregnancy test and must be non-lactating; men should agree to must use contraception during the study period and for 6 months after the end of the study period.
Exclusion criteria
Exclusion criteria: 1. Large cell carcinoma and mixed cell lung cancer; 2. Imaging shows that the tumor has invaded around important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study; or there are obvious lung cavity or necrotic tumors; 3. Received any systemic anticancer therapy for NSCLC, including cytotoxic drug therapy, immunotherapy, and experimental therapy; 4. Local radiotherapy for NSCLC; 5. Patients with other cancers other than NSCLC within five years prior to the start of treatment in this study, excluding cervical carcinoma in situ, cured basal cell carcinoma, bladder epithelial tumors [including Ta and Tis]; 6. Patients who have used anlotinib and other anti-angiogenic drugs in the past; 7. Previous use of PD-1, or other anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, and any other antibody or drug therapy targeting T cell costimulation or checkpoint pathways, such as ICOS or agonists (such as CD40, CD137, GITR, OX40, etc.); 8. Hypersensitivity to apatinib or any component of PD-1 or chemotherapy drugs; 9. Patients with multiple factors that affect oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.); 10. Patients with any severe and/or uncontrolled disease, including: (1) Patients with unsatisfactory blood pressure control (systolic blood pressure >= 150 mmHg, diastolic blood pressure >= 100 mmHg); (2) Patients with myocardial ischemia above grade I or Myocardial infarction, arrhythmia (including QTc >= 480ms) and >= grade 2 congestive heart failure (New York Heart Association (NYHA) classification); (3) Abnormal coagulation function (INR>1.5 or prothrombin time (PT)>ULN +4 seconds or APTT >1.5 ULN), bleeding tendencies or receiving thrombolytic or anticoagulant therapy; Note: Low-dose heparin for prophylactic purposes is permitted provided the international normalized ratio (INR) of prothrombin time is 10 mmol/L); (9) Routine urine indicates urine protein >=++, and confirmed 24-hour urine protein quantification > 1.0g; (10) Has epileptic seizures; (11) Long-term unhealed wounds or fractures, etc.; (12) Clinically significant hemoptysis (more than 50ml of hemoptysis per day) within 2 weeks before enrollment; or significant clinically significant bleeding symptoms or definite bleeding Predisposition, such as gastrointestinal bleeding, bleeding gastric ulcer, fecal occult blood ++ or above at baseline, or suffering from vasculitis; 11. Past interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring hormone therapy, or any active interstitial lung disease with clinical evidence; 12. Those who have experienced arterial/venous thrombotic events within 6 months, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism; 13. Peripheral neuropathy with >=CTCAE grade 2, except for trauma; 14. Patients who need to undergo total right
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;Preoperative objective response rate;1-year event-free survival rate;Event-free survival;Overall survival;Adverse events; | — |
Countries
China
Contacts
Public ContactMeng Wang
Tianjin Medical University Cancer Institute & Hospital
Outcome results
None listed