simultaneous multi-primary non-small cell lung cancer
Conditions
Interventions
The experimental group:preoperative camrelizumab combined with platinum-containing two-drug chemotherapy
The control group:Immediate surgery
Sponsors
Jiangsu Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 70, regardless of gender; 2. Stage IB-II resectable simultaneous multiple primary non-small cell lung cancer confirmed by histopathology or cytology; 3. No previous local or systemic treatment for primary lung cancer; 4. At least one measurable lesion (according to RECIST 1.1 criteria) with negative EGFR/ALK and other driver genes; 5. Subjects must have sufficient lung function to tolerate pneumonectomy; 6. At enrollment, the World Health Organization (WHO)/Eastern Oncology Collaboration (ECOG) Physical status Score (PS) was 0 or 1; 7. Life expectancy >= 3 months; 8. The subject signed the informed consent and voluntarily joined the study; 9. There is no serious liver or kidney function injury, and the functional level of the organ must meet the following requirements: The ANC acuity 1.5 x 10^9 / L;PLT acuity 90 x 10^9 / L;Hb >= 90 g/L;1 x ULN TBIL or less;ALT and AST = 50 mL/min (Cockcroft-Gault formula);LVEF 50% or higher;Fridericia method corrected QT Interval (QTcF) in men <450 ms, female <470 ms;INR <= 1.5 x ULN, ACTT<= 1.5 x ULN.
Exclusion criteria
Exclusion criteria: 1. Subjects with allergies or hypersensitivity to therapeutic drugs, subjects with autoimmune diseases; 2. There is a third space effusion (such as massive pleural effusion and ascites) that cannot be controlled by drainage or other methods; 3. Use of steroids for more than 50 days, or require long-term use of steroids; 4. Those with uncontrolled symptomatic brain metastases or mental disorders that cannot correctly express subjective symptoms; 5. Receive any other anti-tumor therapy at the same time, including anti-tumor Chinese patent medicines and immune preparations; 6. Other malignant tumors occurred within 5 years before enrollment, except for cervical carcinoma in situ or skin squamous or basal cell carcinoma previously treated for radical cure; 7. Pregnant or lactating women, those who are fertile but refuse to take contraceptive measures; 8. Those with serious heart disease or medical history, including: documented history of congestive heart failure, high-risk uncontrolled arrhythmia, angina pectoris requiring drug treatment, clinically definite heart valve disease, history of severe myocardial infarction and intractable high blood pressure; 9. Received allogeneic tissue/solid organ transplantation; 10. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the research (such as uncontrolled hypertension, diabetes, thyroid disease, etc.); 11. The investigator determines other circumstances that are not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| remission rate; | — |
Countries
China
Contacts
Public ContactHe Jing
Jiangsu Provincial People's Hospital
Outcome results
None listed