Lung cancer
Conditions
Interventions
single arm: anrotinib and gefitinib
Sponsors
Department of Oncology, Ya'an People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Over 18 years old, with a life expectancy of more than three months; 2. Performance status (PS) : 0-2; 3. Histological diagnosis of EGFR mutation-positive IIB(not suitable for surgery or radiotherapy) to stage IV non-small cell lung cancer; 4. According to the evaluation criteria of RECIST1.1 solid tumor, there was at least one measurable lesion; 5. Slow progress after receiving or receiving generation TKI treatment 6. The main organ functions normally, that is, it meets the following criteria: blood routine: HB >= 90g/L (no blood transfusion or EPO dependence within 14 days); The ANC acuity 1.5 x 10^9 / L; PLT acuity 100 x 10^9 / L; Blood biochemistry: TBIL = 60ml/min; Urine protein was less than 2+ in routine examination, or the 24-hour urine protein quantity was less than 1g. Coagulation function was good, INR and PT = normal low limit (50%); 7. Women of child-bearing age must have taken reliable contraceptive measures or had a negative pregnancy test (serum or urine) within 7 days prior to enrollment and be willing to use appropriate methods of contraception during the trial and 8 weeks after the last dose of the test drug. For men, consent must be given to appropriate methods of contraception or surgical sterilization during the trial period and 8 weeks after the last administration of the trial drug; 8. Subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Subjects with non-small cell lung cancer of other histopathological types, including subjects with mixed adenosquamous carcinoma (squamous cell carcinoma accounts for >= 10%) and NSCLC subjects containing components of small cell lung cancer; 2. Previously received targeted therapy of VEGF pathway including anrotinib and bevacizumab; 3. Symptomatic brain metastases (patients with brain metastases who have completed treatment 21 days before admission and have stable symptoms can be admitted into the group, but no symptoms of cerebral hemorrhage should be confirmed by craniocerebral MRI, CT or intravenous contrast evaluation): 4. CT or MRI showed tumor lesions located more than 5mm away from the great vessels, or there was a central tumor invading the local great vessels. Or showing significant pulmonary cavitation or necrotizing tumors; 5. Hypertensive patients who are being treated with a combination of two or more antihypertensive drugs; 6. Hemoptysis of 2 teaspoons or more per day before inclusion; 7. Had significant clinical bleeding symptoms or had a clear bleeding tendency in the first 3 months, such as gastrointestinal bleeding, hemorrhagic hemorrhoids, hemorrhagic gastric ulcer, fecal occult blood ++ or above at baseline, or had vasculitis, etc.; 8. Patients with significant factors affecting oral drug absorption (such as inability to swallow, gastrointestinal tract resection, chronic diarrhea and intestinal obstruction, etc.); 9. Pregnant or nursing women; Patients with fertility who are unwilling or unable to use effective contraception; 10. The researcher judged other conditions that might affect the conduct of the clinical study and the judgment of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Public ContactZikang.Li
Ya'an People's Hospital
Outcome results
None listed