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The study for apatinib combined with egfr-tki in the treatment of non-small cell lung cancer patients with EGFR mutation

The study for apatinib combined with egfr-tki in the treatment of non-small cell lung cancer patients with EGFR mutation

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900023837
Enrollment
Unknown
Registered
2019-06-14
Start date
2019-06-30
Completion date
Unknown
Last updated
2019-06-17

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

treatment group:Apatinib combined with EGFR-TKI

Sponsors

Shanxi Provincial Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Above 18 years old and below 75 years old, regardless of gender; 2. The pathology diagnosed late (III, III C and B IV period) the scales, and non-small cell lung cancer, with a measurable lesion (tumor lesions on CT scan length to diameter 10 mm, or lymph node lesions on CT scans short diameter 15 mm or higher, scanning layer thickness is not more than 5 mm); 3. Patients with drug resistance treated with egfr-tki (including erlotinib, gefitinib and echtinib); 4. There is no interventional systemic treatment between cessation of gefitinib or erlotinib and initiation of new treatment; 5. ECOG score: 0-2; 6. Expected survival time =3 months; 7. Main organs are functioning normally, which means they meet the following criteria (no blood transfusion and blood products within 14 days, no correction with g-csf and other hematopoietic stimulators): (1) blood routine examination standards shall meet: A. HB 90 g/L or higher; B. the ANC acuity 1.5 x 10^9 / L; C. PLT acuity 80 x 10^9 / L; (2) biochemical examination shall meet the following standards: A. TBIL 45 mL/min. 8. Women of reproductive age must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and voluntarily use appropriate methods of contraception during observation and within 8 weeks after the last apatinib tablet; For men, surgical sterilization or consent to appropriate contraceptive methods during observation and within 8 weeks after the last apatinib tablet is given; Patients volunteered to participate in the study and signed an informed consent form (ICF).

Exclusion criteria

Exclusion criteria: 1. Persistent clinical treatment-related toxicity associated with previous chemotherapy and/or radiotherapy; 2. Receive radiotherapy (except for limbs and brain) within 3 months prior to baseline imaging examination; 3. Active brain metastasis or pneumomeningeal disease; 4. Radiological evidence suggests the presence of vacuous or necrotizing tumors; 5. Radiological evidence (CT or MRI) indicates the presence of a central tumor that invades local large vessels; 6. Clinically significant hemoptysis in the past 3 months; 7. Receiving anticoagulants or antiplatelet drugs; 8. Abnormal coagulation function (INR>1.5×ULN, APTT>1.5×ULN), with bleeding tendency; 9. Severe thrombus or clinically related severe bleeding event in the past 6 months; The presence of hereditary bleeding or thrombosis tendency; 10. Patients with hypertension who cannot drop to the normal range after antihypertensive medication (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); The investigators determined other conditions that might influence the outcome of clinical studies.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
Objective remission rate;Disease control rate;

Countries

China

Contacts

Public ContactSong Xia

Shanxi Provincial Cancer Hospital

hrsxshizheng@163.com+86 18360638595

Outcome results

None listed

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