Non-Small Cell Lung Cancer
Conditions
Interventions
Case series:Anlotinib Combine With EGFR-TKI
Sponsors
Nantong Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged from 18 to 75 years, Life expectancy >=12 weeks; 2. Histologically or cytologically documented inoperable, locally advanced (Stage IIIb), metastatic (Stage IV) or recurrent NSCLC; 3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2; 4. At least one measurable lesion (helical CT scan long diameter >=10mm, meet the requirements of the standard Response Evaluation Criteria In Solid Tumors(RESCIST) version 1.1); 5. Slow progress after receiving TKI treatment; 6. Adequate organ function as follows: Absolute neutrophils count (ANC) >1.5x10^9/L (band neutrophil and segmented neutrophil), platelets > 100x10^9/L and Hb>=90g/L; Hepatic: total bilirubin less than or equal to 1.5 ULN; Alkaline phosphatase (AP), alanine transaminase (ALT) and aspartate transaminase (AST) less than or equal to 3.0 ULN (or less than or equal to 5 ULN in case of known liver involvement; Renal: Serum Creatinine less than or equal to 1.25 ULN; 7. Females of child-bearing potential must have negative serum pregnancy test. Sexually active males and females (of childbearing potential) willing to practice contraception during the study; 8. Signed Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. Unhealed toxicity of prior anti-cancer treatment (CTCAE Level 1) or surgery; 2. Symptomatic Central Nervous System (CNS) metastases; 3. Arterial thrombosis or venous thrombosis in 6 months, or disposition evidence of thrombosis/bleeding in 2 month , hemoptysis in 2 weeks (bright red blood, 1/2 teaspoon); 4. Cardiac function evaluation: LVEF =NYHA 2; 5. Prior other malignant disease in 5 years (except carcinoma in situ of cervix, or non melanoma skin cancers, or localized prostate cancer with Gleason <=6); 6. Difficulty swallowing or known malabsorption; 7. Pregnant or lactating woman; 8. Evidence of tumour invading major blood vessels on imaging. The investigator or the local radiologist must exclude evidence of tumour that is fully contiguous with, surrounding, or extending into the lumen of a major blood vessel (e.g., pulmonary artery or superior vena cava); 9. Treatment with any other investigational agent or participation in another clinical trial within 28 days; 10. Other conditions regimented at investigators' discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;disease control rate;objective response rate; | — |
Countries
China
Contacts
Public ContactXiaodong Zhang
Nantong Tumor Hospital
Outcome results
None listed