Advanced non-small cell lung cancer
Conditions
Interventions
Experimental group:Jinfukang oral liquid oral, 30ml once a day, 3 times a day +First-line chemotherapy
Control group:First-line chemotherapy
Sponsors
First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Pathology confirmed as non-small cell lung cancer, at least one measurable lesion, and inoperable stage III, IV and phase II patients who refused surgery; 2. Aged 18-70 years; 3. ECOG score 0~2 points; 4. The estimated survival period is more than 3 months; 5. The main organ function meets the following criteria within 7 days before treatment: (1) blood routine examination criteria (without blood transfusion within 14 days): 1 hemoglobin (HB) = 90g / L; 2 neutrophil absolute value (ANC) = 1.5 × 10^9 / L; 3 platelets (PLT) = 80 ×10^9/L. (2) Biochemical examination should meet the following criteria: 1 total bilirubin (TBIL) = 1.5 times the upper limit of normal (ULN); 2 alanine aminotransferase (ALT) and aspartate aminotransferase AST = 2.5ULN For example, with liver metastasis, ALT and AST = 5ULN; 3 serum creatinine (Cr) = 1.5ULN or creatinine clearance (CCr) = 60ml / min; (3) Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) = normal low limit (50%). 6. Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy tests within 7 days prior to study enrollment, It must be a non-lactating patient; men should agree to patients who must use contraception during the study period and within 6 months of the end of the study period. 7. Subjects have good compliance and signed informed consent, which can be used in conjunction with relevant examinations and follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with drug allergy to the first-line chemotherapy treatment plan in the program; 2. Pregnant women, lactating women; 3. Previously received first-line system anti-tumor therapy for advanced non-small cell lung cancer (including systemic chemotherapy, molecular targeted drug therapy, biological therapy, and other research and treatment drugs); 4. Accompanied by pleural effusion or ascites caused by respiratory syndrome (according to NCICTCAE grade = 2 dyspnea). 5, 5 years or currently have other malignant tumors, cured cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors except [Ta (non-invasive tumor), Tis (in situ cancer) And T1 (tumor infiltrating basement membrane)]; 6. Plan for systemic anti-tumor therapy within 4 weeks prior to grouping or during the study, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or use of M. serrata within 6 weeks prior to receiving the test drug) C). Radiation-rehabilitation radiotherapy (EF-RT) was performed within 4 weeks before grouping or limited-field radiotherapy to be evaluated for tumor lesions within 2 weeks before grouping; 7. Unresolved toxicity due to any previous treatment above CTCAE (5.0) level 1 excluding alopecia; 8. Have a variety of factors affecting oral drugs (such as unable to swallow, chronic diarrhea and intestinal obstruction, etc.); 9. Patients with brain metastases or pial meningeal metastases. 10. Patients with any severe and/or uncontrolled disease, including: (1) Patients with unsatisfactory blood pressure control (systolic blood pressure =150 mmHg, diastolic blood pressure =100 mmHg); (2) Serious infections that are active or uncontrolled (=CTCAE grade 2 infection); (3) Renal failure requires hemodialysis or peritoneal dialysis; (4) A history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; (5) Urine routine indicates that urine protein = ++, and confirmed 24-hour urine protein quantitation > 1.0 g; (6) Patients with a history of seizures and requiring treatment; 11. Received major surgical treatment, incisional biopsy or significant traumatic injury within 28 days prior to grouping; 12. Patients with any signs of hemorrhage or medical history, regardless of severity; patients with any bleeding or bleeding episodes = CTCAE 3 within 4 weeks prior to grouping have unhealed wounds, ulcers or fractures; Overactive or venous thrombosis occurred within 13 or 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism; 14. Those who have a history of abuse of psychotropic substances and are unable to quit or have mental disorders; 15. Participated in other clinical trials of anti-tumor drugs within four weeks; 16. According to the judgment of the investigator, there is a concomitant disease that seriously harms the patient's safety or affects the patient's completion of the study; 17. The investigator believes that patients are not eligible to participate in other situations in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lung cancer patient quality of life measurement scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;Solid tumor remission evaluation;Immune index;Tumor markers;Progress free survival time; | — |
Countries
China
Contacts
Public ContactMa Wang
Department of Oncology, First Affiliated Hospital of Zhengzhou University
Outcome results
None listed