Non-small cell lung cancer
Conditions
Interventions
therapeutic response group + therapeutic nonresponse group: Platinum-based chemotherapy
Sponsors
The Third Affiliated Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age is 18 to 75 years; 2) ECOG performance status (PS) level 0~2; 3) The estimated lifetime is not less than 12 weeks; 4) Pathologically confirmed patients with stage III and IV NSCLC have measurable lesions (according to RECIST 1.1, CT scan long diameter >= 10mm, lymph node lesion CT scan short diameter >= 15mm, measurable lesions have not received radiotherapy, Local treatment such as freezing); 5) All patients received platinum-based chemotherapy with the following reagents: cisplatin 75 mg / m2 on day 1; carboplatin on day 1 6.0 mg / ml / min; docetaxel 75 mg / m2, day 1; gemcitabine On day 1 and day 8, 1,250 mg / m2; vinorelbine (NVB) on day 1 and day 8 25 mg / m2; pemetrexed (PEM) on day 1 500 mg / m2. All chemotherapy drugs are administered intravenously and the treatment is repeated every 3-4 weeks. 8) The main organs function normally, that is, the following criteria are met: (1) Blood routine examination standards must meet: a) ANC >= 1.5 x 10 ^ 9 / L; b) PLT >= 100 x 10 ^ 9 / L; c) Hb >= 100g/L; (No blood transfusion and blood products within 14 days, not corrected by G-CSF and other hematopoietic stimuli) (2) Biochemical examinations must meet the following criteria: a) TBIL = 50ml/min (Cockcroft-Gault formula). 9) Women of childbearing age must have taken reliable contraceptive measures or performed a pregnancy test (serum or urine) within 7 days prior to enrollment and the results were negative and willing to use appropriate methods during the trial and 8 weeks after the last administration of the test drug. contraception. For men, consent must be given to the appropriate method of contraception or surgical sterilization during the trial and 8 weeks after the last administration of the test drug; 10) Subjects voluntarily joined the study and signed informed consent, with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1) Symptomatic brain metastasis (patients with brain metastases who have completed treatment and have stable symptoms 21 days before enrollment can be enrolled, but need to be confirmed by brain MRI, CT or venography to have no cerebral hemorrhage symptoms); 2) Imaging (CT or MRI) shows that the tumor lesion is = 450 ms, women >= 470 ms); according to NYHA criteria, grade III to IV cardiac function Incomplete, or cardiac color Doppler examination revealed a left ventricular ejection fraction (LVEF) 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), with bleeding tendency or receiving thrombolysis or anticoagulant therapy; 7) known hereditary or acquired bleeding and thrombophilia (such as hemophilia patients, coagulopathy, thrombocytopenia, hypersplenism, etc.); 8) Those who have a history of psychotropic substance abuse who are unable to quit or have a mental disorder; 9) Participated in other clinical trials of anti-tumor drugs within 4 weeks before enrollment; 10) with or without other unhealed malignant tumors, except for cured skin basal cell carcinoma, cervical carcinoma in situ, and superficial bladder cancer; 11) pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Suppressor of cytokine signaling 3 protein; | — |
Countries
China
Contacts
Public ContactJinhong Wang
The Third Affiliated Hospital of Southern Medical University
Outcome results
None listed