Tumor
Conditions
Interventions
the test group:shenyi Capsule+chemotherapy
Sponsors
Jilin provincial tumor hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Above 18 years of age, sex not limited; 2. The histological and / or cytologically confirmed a (naive) IV NSCLC patients; the first (Chu Zhi) were defined as not received radiation, chemotherapy or assisted resection of the end of chemotherapy patients of recurrence or metastasis 6 months after; 3. ECOG score =3 months; 5. The main organ function well in the 7 days before randomization, defined as: Absolute neutrophil count >=2000/mm3; Platelet count >=100000/mm3; HB >=9.0g/dl; Alanine aminotransferase <=2.5*ULN; Glutamic oxaloacetic transaminase <=2.5*ULN; Total bilirubin <=1.5*ULN; 6. Oral drugs; 7. According to the RECIST1.1 standard at least one measurable lesion measurable lesions by any of the following methods: at least accurate focus single size, chest or abdominal computed tomography (CT) or nuclear magnetic resonance (MRI), the conventional method of diameter of at least 20mm or application of spiral CT diameter of at least 10mm; 8. Age in male and female patients entered the trial, in the course of the study until 30 days after drug withdrawal must use reliable methods of contraception; 9. Can understand this trial and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Known to the ginseng saponin, Changchun vinorelbine, paclitaxel and cisplatin and its accessories in allergic patients; 2. At the beginning of received study medication within 6 weeks before received radical radiotherapy. At the beginning of received study medication within 2 weeks before received local palliative radiotherapy; 3. Brain metastasis symptoms (patients with stable disease and do not need treatment of asymptomatic brain metastases can be randomly); 4. The past received containing Changchun vinorelbine, paclitaxel chemotherapy, NP, TP regimen adjuvant chemotherapy completion of >=1 years after subjects recurrence can be selected; 5. The other clinical trials in 1 months before randomization; 6. Doctors believe that doesn't fit in the subjects; 7. There are serious, and severe or not control of physical or mental illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CTLA-4;PD-1;PDL1; | — |
Countries
China
Contacts
Public ContactZhang Yue
Jilin provincial tumor hospital
Outcome results
None listed