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A real-world study of apatinib combined with gefitinib in the treatment of EGFR-positive advanced NSCLC

A real-world study of apatinib combined with gefitinib in the treatment of EGFR-positive advanced NSCLC

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000038960
Enrollment
Unknown
Registered
2020-10-10
Start date
2020-10-10
Completion date
Unknown
Last updated
2021-01-11

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

Conditions

Non-small cell lung cancer

Interventions

Apatinib combined with EGFR-TKI:no

Sponsors

Shanxi Tumor Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The age of patients >= 18 years old is not limited to men and women; 2. EGFR positive patients with advanced NSCLC include: (1) First line treatment for patients with recurrence or metastasis (patients with recurrence within 6 months after completion of adjuvant therapy were allowed to be enrolled); Note: chemotherapy or EGFR TKIs are allowed for adjuvant therapy. (2) Patients who can continue to use EGFR TKIs after the progress of first-line EGFR TKIs treatment; 3. Patients with pathologically confirmed advanced (III B and above) non-small cell lung cancer have measurable lesions (the long diameter of tumor lesions on CT scan is >= 10 mm, the short diameter of lymph node lesions on CT scan is >= 15 mm, and the scanning slice thickness is not more than 5 mm); 4. ECoG score: 0-2; 5. Patients with an estimated survival time of more than 3 months; 6. Patients with normal function of main organs, i.e. those who meet the following criteria (no blood transfusion or blood products within 14 days, no correction with G-CSF or other hematopoietic stimulating factors): 7. (1) the standard of blood routine examination should meet the following requirements: HB >= 90 g/L ANC >= 1.5 x 10^9/L PLT >= 80 x 10^9/L (2) Biochemical tests should meet the following standards: TBIL 45 ml / min. 8. Women of childbearing age must have negative pregnancy test (serum or urine) results within 7 days before enrollment, and voluntarily use appropriate contraceptive methods during the observation period and within 8 weeks after the last administration of apatinib; for men, it should be surgical sterilization, or agree to use appropriate contraceptive methods during the observation period and within 8 weeks after the last administration of apatinib; 9. The patients who voluntarily joined the study signed the informed consent; 10. The researchers think it can benefit.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Patients with contraindications of apatinib or EGFR TKIs (such as active bleeding, ulcer, intestinal perforation, intestinal obstruction, uncontrollable hypertension, III-IV cardiac insufficiency, within 30 days after major surgery, severe liver and renal insufficiency, etc.) 3. Patients with persistent clinical treatment-related toxicity related to previous chemotherapy and / or radiotherapy; 4. Patients receiving radiotherapy within 3 months before baseline imaging examination (except limbs and brain); 5. Patients with active brain metastasis or leptomeningeal disease; 6. Patients with cavitary or necrotic tumor according to radiological evidence; 7. Radiologic evidence (CT or MRI) showed that there were central tumors invading local large vessels; 8. Patients with clinically significant hemoptysis in the past 3 months; 9. Patients treated with anticoagulants or antiplatelet drugs; 10. Patients with abnormal coagulation function (INR > 1.5 x ULN, APTT > 1.5 x ULN), patients with bleeding tendency; 11. Patients with severe thrombosis or clinically related severe bleeding events in the past 6 months; patients with hereditary bleeding or thrombosis tendency; 12. Patients with hypertension who can not be reduced to normal range after antihypertensive drug treatment (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 13. The researcher judges other situations that may affect the judgment of clinical research results. 14. Patients considered unsuitable by doctors.

Design outcomes

Primary

MeasureTime frame
progression free survival;

Countries

China

Contacts

Public ContactWenzhong Su

Shanxi Tumor Hospital

458597129@qq.com+86 15525112001

Outcome results

None listed

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