advanced non-small cell lung cancer
Conditions
Interventions
Combination therapy group:Anlotinib hydrochloride capsule -10 mg -oral administration daily for two weeks, Q3W
Vinorelbine soft capsule -30 mg -Oral administration every Monday, Wednesday, Friday
Sponsors
Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
60 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Histopathological examination confirmed advanced non-small cell lung cancer (NSCLC) with no EGFRALKROS1 drive gene mutation. 2. Aged >= 65 years. 3. ECOG PS score is 0 or 1. 4. Subjects must undergo second-line palliative therapy (first stage), or refuse to chemotherapy when first-visit or undergo first-line therapy (second stage). 5. With adequate organ and bone marrow functions, as defined below: 1) Blood routine: absolute neutrophil count (ANC) >= 1.5 x 10^9/L; platelet count (PLT) >= 100 x 10^9/L; hemoglobin (HGB)>= 9.0; 2) Liver function: patients without liver metastasis required serum total bilirubin (TBIL) = 60 mL/min (calculated by Cockcroft/Gault formula): Women: Ccr=(140-age) x weight (kg) x 0.85 Serum creatinine x 72(mg/dL) 4) The coagulation function is sufficient, defined as the international standardized ratio (INR) or prothrombin time (PT) = 12 weeks. 7. Women of childbearing age are required to use effective contraception throughout the treatment period and 6 months after treatment. Sign written informed consent and be able to follow the visit and related procedures specified in the program.
Exclusion criteria
Exclusion criteria: 1. Previously received systemic therapy such as EGFR TKI or ALK inhibitors. 2. Previous (first-line or adjuvant treatment stage) treatment with the inclusion of anlotinib hydrochloride and/or vinorelbine regimen. 3. Patients had mid-to-large pleural or peritoneal effusions requiring medical intervention at baseline. 4. Also participate in another intervention clinical study, unless involved in an observational (non-intervention) clinical study or at the follow-up stage of the intervention study. 5. Patients who had previously undergone total pneumonectomy or total lung radiotherapy. 6. Symptomatic central nervous system metastases and/or cancerous meningitis are known. For previously treated brain metastases, participants may participate if the patient's condition is stable (no evidence of imaging progression at least 4 weeks prior to initial administration of the trial treatment), repeated imaging tests confirm no evidence of new brain metastases or enlargement of the original brain metastases, and no steroid treatment is required at least 14 days prior to initial administration of the trial treatment. This exception does not include cancerous meningitis and should be excluded regardless of its clinical status. 7. Known to have active tuberculosis. 8. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 9. Known to be allergic to any antinib hydrochloride capsule and/or vinorelbine soft capsule preparation or excipient composition. 10. Known presence of HIV infected (HIV antibody positive). 11. Severe infection in active or clinically poorly controlled. 12. Symptomatic congestive heart failure (grade II-IV of the new york heart association) or symptomatic or poorly controlled arrhythmias. 13. Uncontrolled arterial hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg) even when given standard treatment. 14. Any arterial thromboembolic events, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, occurred within 6 months prior to the admission to treatment. 15. Have a history of deep venous thrombosis, pulmonary embolism, or any other severe thromboembolism within 3 months prior to admission (implantable intravenous infusion port or catheter-derived thrombosis, or superficial venous thrombosis is not considered "severe" thromboembolism). 16. Hepatic encephalopathy, hepatorenal syndrome or grade Child-Pugh B or more severe cirrhosis. 17. History of intestinal obstruction or the following diseases: inflammatory bowel disease or extensive bowel resection (partial or extensive bowel resection with chronic diarrhea), crohn's disease, ulcerative colitis. 18. Known to have acute or chronic active hepatitis B (HBsAg positive and HBV DNA viral load >= 103 copy number/ mL or > 200 IU/ml) or acute or chronic active hepatitis c (HCV antibody positive and HCV RNA positive). 19. Had a history of gastrointestinal perforation and/or fistula within 6 months prior to the inclusion study. 20. With interstitial lung disease requiring steroid hormone therapy. 21. History of other primary malignancies except: Complete remission of malignant tumors for at least 2 years before admission and no other treatment is required during the study period; Non-melanoma skin cancer or malignant freckle-like nevus with adequate treatment and no evidence of disease recurrence; Carcinoma in situ after adequate tre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactZhao Qiong
Shulan (Hangzhou) Hospital
Outcome results
None listed