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Apatinib mesylate tablets combined with gefitinib in the treatment of non-small cell lung cancer with gefitinib T790M mutation, single center, open, single arm clinical study

Apatinib mesylate tablets combined with gefitinib in the treatment of non-small cell lung cancer with gefitinib T790M mutation, single center, open, single arm clinical study

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800014428
Enrollment
Unknown
Registered
2018-01-13
Start date
2018-01-12
Completion date
Unknown
Last updated
2018-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer

Interventions

Case series:apatinib

Sponsors

Xijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. aged 18 to 70 years old; 2. patients with advanced non-small cell lung cancer diagnosed by histopathology or cytology (stage IV) have at least one measurable lesion and meet the RECIST criteria; 3. ECOG PS score: 0-2 points; 4. patients who had previously received gefitinib treatment, who had been tested for T790M mutations, were unable or unwilling to receive AZD9291 treatment; 5. the main organ function is normal, that is to meet the following standards: 1) routine blood test criteria should be consistent (within 14 days no blood transfusion and blood products, not using G-CSF and other hematopoietic stimulation factor correction): HB = 90 g/L; ANC = 1.5 * 10^9/L; PLT = 80 * 10^9/L; (2) biochemical examination should meet the following standards: TBIL 45 ml/min (Cockcroft-Gault formula, see Appendix 3); 6. more than the expected survival time in March; 7. patients with asymptomatic brain metastases had stable clinical symptoms for at least 2 months before admission; 8. women of childbearing age must be a pregnancy test in 7 days before entering the group (in serum), and the results were negative, and willing to contraception during the study period and the last 8 weeks after giving drug test using appropriate; for men, for surgical sterilization, or to contraceptive methods during the test and the last time to test drug after 8 weeks by appropriate; 9. subjects voluntarily joined the study, signed informed consent, good compliance, and followed up.

Exclusion criteria

Exclusion criteria: 1. pregnant or lactating women; 2. imaging (CT or MRI) showed tumor lesions from large vessels, or are less than or equal to 5mm central tumor vessels or local invasion; there was a pulmonary cavity or necrotic tumor; 3. with serious heart, liver and kidney diseases; symptomatic brain metastases were not controlled; neurologic and mental diseases were associated with severe infection; 4. patients with hypertension and antihypertensive drugs can not be reduced to the normal range (systolic pressure >140 mmHg, diastolic pressure >90 mmHg); 5. patients with coronary heart disease above I and arrhythmia (including QTc interval prolonged male > 450 ms, female > 470 MS) and cardiac insufficiency; 6. in group 2 months before there was blood, cough or hemoptysis daily capacity of 2.5ml or above; 7. before entering the group within 3 months had clinically significant bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, baseline fecal occult blood + + and above, or suffering from vasculitis; 8., in the first 12 months of the admission, there were thromboembolism events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism. 9. abnormal coagulation function (INR>1.5, APTT>1.5 ULN), with bleeding tendency; 10. patients with a history of cardiovascular and cerebrovascular diseases, and still oral thrombolytic drugs or anticoagulants. 11. urine protein positive patients (urine protein test 2+ or above, or 24 hour urine protein quantitative >1.0g); 12. according to the researchers' judgment, there are other serious harm to patients who are safe or affect patients who have completed the study with the disease. 13.Researchers believe that it is not suitable for the participants.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
OS;DCR;ORR;

Countries

China

Contacts

Public ContactQianrong Wang

Xijing Hospital

15109224579@163.com+86 15109224579

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026