Non-small cell lung cancer (NSCLC)
Conditions
Interventions
CONTROL group:Camrelizumab combined with chemotherapy and local consolidation therapy
Sponsors
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The age of signing the informed consent is 18-75 years old, both male and female; 2. Non-small cell lung cancer diagnosed by cytology or histology should be classified as stage IV with oligometastasis according to the 8th edition TNM staging criteria of the International Association for the Study of Lung Cancer (IASLC), or oligometastatic non-small cell lung cancer with recurrence/metastasis after radical treatment such as surgery, radiotherapy, chemoradiotherapy, etc. (Oligometastasis is defined as the number of metastatic organs =6 months from the end of treatment to recurrence or metastasis. 5. Subject must have at least one measurable lesion according to RECIST 1.1 (a lesion that has received radiation must show clear progression to be a measurable lesion). 6.ECOG PS score: 0-1. 7. Expected survival >=3 months. >= s must meet the following standards: 1) Blood routine test: (No blood transfusion or use of G-CSF and other cytokine drugs for correction within 2 weeks before screening); Hb >= 90 g/L; ANC >= 1.5×10^9/L; PLT >= 90×10^9/L; WBC >= 3.0×10^9/L and = 50 mL/min (Cockcroft-Gault formula); 4) Thyroid function: TSH <= 1×ULN (if abnormal, FT3 and FT4 levels should be examined simultaneously; if FT3 and FT4 levels are normal, enrollment is allowed); 5) Coagulation function: APTT <= 1.5×ULN, and INR or PT <= 1.5×ULN. 9. Non-surgical sterilization or female patients of childbearing age must undergo a serum pregnancy test within 3 days before the first medication, and the result is negative; And must be non-lactating. Female patients of reproductive age or male patients whose partners are women of reproductive age must consent to use highly effective methods of contraception during the study period and for 6 months after the last dose of the study drug. 10. The patient voluntarily joined the clinical study and signed the informed consent, with good compliance and able to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Those who have previously received immunotherapy, including but not limited to anti-PD-1 /PD-L1 monoclonal antibody and anti-CTLA-4 monoclonal antibody therapy. 2. Brain metastases accompanied by clinical symptoms, meningeal metastasis, spinal cord compression, etc. - Patients who have received previous treatment for brain metastases (radiotherapy or surgery), have stopped systemic hormone therapy (dose > 10mg/ day prednisone or other equivalent hormone), and have no clinical symptoms can be enrolled. 3. Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion with clinical symptoms. - If fluid drainage is performed (except for diagnostic pleural puncture), patients who have been stable for at least 2 weeks after drainage can be enrolled (local treatment of the serosal cavity is allowed according to clinical practice before signing the notification). 4. Patients with other malignant tumors within the past 5 years or at the same time, except cured skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma, cervical carcinoma in situ, and breast ductal carcinoma in situ. 5. People who have previously received allogeneic tissue/solid organ transplantation. 6. Past or current interstitial pneumonia/interstitial lung disease (except for those with imaging changes only), pneumonia requiring treatment with the glucocorticoid system (such as radiation pneumonia). 7. Patients with any active or known autoimmune disease were admitted for type 1 diabetes treated with stable dose insulin, Hashimoto thyroiditis, hypothyroidism or hypoadrenal dysfunction requiring hormone replacement therapy, no systemic therapy, and no acute worsening skin disease (such as eczema, vitiligo, or psoriasis) within 1 year prior to the screening period. Patients with asthma requiring medical intervention with bronchodilators are not included. 8. Patients with active pulmonary tuberculosis. Participants could be enrolled after adequate treatment and anti-tuberculosis treatment for >= 1 month before enrollment. 9. Clinical symptoms or diseases of the heart that are not well controlled, such as: (1) NYHA grade 2 and above heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention. 10. Had received major surgical treatment within 4 weeks prior to enrollment and local treatment within 2 weeks prior to enrollment, failed to recover from toxicity and/or complications of previous interventions to NCI-CTC AE 38.5? occurred during screening and before first administration. 12. Participants who had received systemic treatment with corticosteroids (>10 mg/ day of prednisone or other equivalent hormone) or other immunosuppressants within 2 weeks prior to enrollment. In the absence of active autoimmune disease, inhaled or topical corticosteroids are permitted, as well as adrenal hormone replacement therapy at doses <=10 mg/ day of prednisone efficacy; 13. A known history of testing positive for the human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). Known to have active
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate,ORR;Overall Survival, OS;Duration of response,DOR;disease control rate, DCR;Safety;Tolerance; | — |
Countries
China
Contacts
Public ContactLinliping
The Affiliated Panyu Central Hospital, Guangzhou Medical University
Outcome results
None listed