lung cancer
Conditions
Interventions
Combination group:Anrotinib combined with chemotherapy
Monotherapy group:Anrotinib alone
Sponsors
Fujian Medical University Union Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. age 18 to 75 years old, male or female; 2. histologically confirmed diagnosis of non-small cell lung cancer; 3. combined with metastatic lesions (not amenable to curative resection); 4. available to provide a test or formally reported biopsy or surgical resection of histological specimens before enrollment; 5. confirmed by CT or MRI, the presence of at least one measurable lesion (non-radiation therapy field) in accordance with RECIST 1.1 criteria; 6. body condition score ECOG 0 to 1; 7. expected survival of more than 3 months, easy to follow up; 8. patients who have progressed after at least two previous systemic chemotherapy or intolerable; 9. patients with driver gene mutation need to have progressed after previous treatment with targeted TKIs. And received at least one systemic chemotherapy 10. Recovered from relevant toxicities of previous treatment before study entry; 11. Voluntarily signed informed consent; 12. Other major organ functions meet the requirements.
Exclusion criteria
Exclusion criteria: 1. Organ function level: Bone marrow: white blood cell (WBC) 1.5 times the upper limit of normal reference value; ALT and AST > 2.5 times the upper limit of normal reference value (without liver metastasis) or > 5 times the upper limit of normal reference value (liver metastasis); kidney: serum creatinine (Cr) > 1.5 times the upper limit of normal or creatinine clearance 50 mL/day) in patients with non-small cell lung cancer; other concomitant anti-tumor therapy; 6. Patients with brain metastasis with symptoms or symptom control for less than 2 months; 7. Patients whose tumors have invaded important blood vessels or are likely to have massive hemorrhage during the subsequent study as judged by the investigator; 8. Patients with any signs or history of hemorrhage; 9. Any unstable systemic disease: active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris starting in the last 3 months, congestive heart failure (New York Heart Association [NYHA] >=II), myocardial infarction within 6 months before enrollment, severe arrhythmia requiring drug treatment, liver, kidney or metabolic disease; 10. in the last 5 years, except for other malignant tumor history of CRC, cured cervical carcinoma in situ, except skin basal carcinoma or squamous cell carcinoma; 11. Participation in other anti-tumor drug clinical trials within 30 days before enrollment; 12.Patients who are receiving hormone therapy other than chronic systemic immunotherapy or physiological replacement therapy; 13. known or self-reported human immunodeficiency virus (HIV) infection; 14. HBV-DNA positive (copy number greater than 103); 15. pregnancy or lactation; 16. Subjects who are known to have alcohol or drug addiction, or other adverse health conditions or mental states that may affect the compliance of the protocol and the assessment of trial indicators in the opinion of the investigator, and are not suitable for participation in the study; 17. Lack or limitation of legal capacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;disease control rate;Progression-free survival; | — |
Countries
China
Contacts
Public ContactXiaoyan Lin
Fujian Medical University Union Hospital
Outcome results
None listed