Non small cell lung cancer
Conditions
Interventions
Acupuncture group:PD-1 inhibitor ( 200mg, q3w ), anti-vascular drug ( 15mg / kg, q3w ) and AP regimen ( pemetrexed 500mg / m2 + cisplatin 75mg / m2, q3w ) were selected. For patients who did not progr
Sham acupuncture group:PD-1 inhibitor ( 200mg, q3w ), anti-vascular drug ( 15mg / kg, q3w ) and AP regimen ( pemetrexed 500mg / m2 + cisplatin 75mg / m2, q3w ) were selected. For patients who did not
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 ~ 75 years old ; 2. NSCLC was confirmed by histopathology or cytopathology, AJCC lung cancer TNM stage IIIB and above ; 3. EGFR mutation was confirmed by tumor histology or cytology or hematology before EGFR-TKI treatment. 4. After EGFR-TKI treatment failure ( based on RECIST V1.1, imaging-confirmed disease progression ), it meets any of the following requirements : (1) .had previously received the first or second generation of EGFR-TKI treatment and failed, and it was necessary to histologically confirm that the EGFR exon 20 T790M mutation was negative ; (2).Previously received first-generation or second-generation EGFR-TKI treatment, and the presence of EGFR exon 20 T790M mutation was confirmed by histology or hematology during treatment or after treatment failure. Subsequently, the third-generation EGFR-TKI ( such as Osimertinib or other third-generation EGFR-TKIs that have been marketed in China ) was received and failed. (3).The third-generation EGFR-TKI treatment failed when the NSCLC with EGFR mutation was first diagnosed. 5.ECOG score 0-2 points ; 6.Predicted survival >= 3 months ; 7.According to the RECIST 1.1 standard, there is at least one measurable lesion ; 8.has sufficient organ function ( Hematology : ANC >= 1500 / mcL, PLT >= 10,0000 / mcL, Hb >= 9.0g / dL or >= 5.6mmol / L ; renal function : serum creatinine clearance rate >= 50mL / min ) ; liver function : serum total bilirubin 1.5ULN but direct bilirubin <= ULN, AST and ALT <= 2.5ULN ( patients with liver metastasis <= 5ULN ) ; endocrine : TSH is normal ; coagulation function : INR, PT, aPTT or PTT < 1.5ULN ( unless receiving anticoagulant therapy ) ; 9.Voluntary to join the study, signed informed consent, good compliance with follow-up.
Exclusion criteria
Exclusion criteria: 1. Those who could not complete the baseline assessment ; 2. Patients with severe primary diseases such as heart, cerebrovascular, liver, kidney and hematopoietic system ; 3.Pregnant women, lactation, mental illness and mental and language disorders ; 4.Combined with autoimmune diseases, blood system diseases, or long-term use of hormones or immunosuppressive agents ; 5. Combined with other primary tumors ; 6. To participate in other clinical trials within 3 months ; 7.Known HIV antibody positive, or other acquired or congenital immunodeficiency disease, or organ transplantation history ( including bone marrow autotransplantation and peripheral stem cell transplantation ) ; 8. Those without legal capacity, medical or ethical reasons that affect the continuation of the study ; 9. The skin ulceration at the acupoint selection site of acupuncture affects the treatment ; 10.Pacemaker implantation ; 11. Acupuncture fear ; 12. Those who received acupuncture treatment within 6 weeks ; 13. Active hepatitis B ( defined as HBsAg positive, the number of HBV-DNA copies detected is greater than the upper limit of the normal value of the laboratory in the study site ; ) 14.Current or previous clinical active interstitial lung disease, active pneumonia, radiation pneumonitis requiring corticosteroids ; 15.Fever and body temperature higher than 38 ° C or clinically significant infection within 1 week before enrollment ; 16. Evidence of active pulmonary tuberculosis, severe or uncontrolled systemic disease ( e.g. severe mental or neurological disease, seizures or dementia, unstable or non-compensatory breathing, cardiovascular, liver or kidney disease, and uncontrolled hypertension [ CTCAE grade 2 or above after drug treatment ] ) ; 17.Patients with active bleeding or new thrombotic diseases who are taking oral anticoagulants or have a tendency to bleed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR;DoR;Quality of life;Lung cancer symptoms; | — |
Countries
China
Contacts
Public ContactHaibo Zhang
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed