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Prospective clinical study for mesylate monotherapy apatinib or combination chemotherapy for after first-line chemotherapy failure advanced non-squamous cell lung cancer

Prospective clinical study for mesylate monotherapy apatinib or combination chemotherapy for after first-line chemotherapy failure advanced non-squamous cell lung cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900022088
Enrollment
Unknown
Registered
2019-03-24
Start date
2019-04-15
Completion date
Unknown
Last updated
2019-03-25

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

Conditions

Lung cancer

Interventions

Apatinib monotherapy group :Apatinib
combined group :Second-line chemotherapy regimen

Sponsors

Ji'nan Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years, male and female; 2. Advanced stage (stage III B, IV) non-squamous and non-small cell lung cancer confirmed by pathology (including histology or cytology) .It has measurable lesions (according to RECIST1.1 standard); 3. Previously treated with standard first-line chemotherapy, patients with drug resistance had been treated. Note: Definition of drug resistance: disease progression (RECIST 1.1 standard assessment) or recurrence during or within 3 months after chemotherapy; 4. ECOG PS: 0-1 points; 5. The expected survival period is greater than or equal to 3 months; 6. The main organ function level is normal; 7. Women of childbearing age should be carried out in the group of 7 days before the pregnancy test (serum or urine), and the results were negative, and willing to during the test and the last to test drugs after 8 weeks, using appropriate methods of contraception; 8. Subjects voluntarily participated in this study, signed informed consent, followed up with good compliance.

Exclusion criteria

Exclusion criteria: 1. Imaging (CT or MRI) shows that the tumor lesion is = 5 mm from the large vessel, or there is a central tumor that invades the local large blood vessel; or that there is a significant pulmonary cavity or necrotizing tumor; 2. People with high blood pressure who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); 3. Myocardial ischemia with above grade II or myocardial infarction, arrhythmia,(including QTc interval male = 450 ms, female = 470 ms); according to NYHA criteria, grade III to IV cardiac insufficiency, or cardiac color Doppler ultrasound examination showed left ventricular ejection fraction (LVEF) 1.0 g; 5. There is obvious coughing blood in the 2 months before enrollment, or daily hemoptysis up to 2.5ml or more; 6. Abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), with bleeding tendency or undergoing thrombolytic or anticoagulant therapy; 7. Long-term unhealed wounds or fractures; 8. Patients with a history of psychotropic substance abuse who cannot be cured or who have mental disorders; 9. The investigators determine other conditions that may affect the conduct of the clinical study and the outcome of the study; 10. Patients with central nervous system metastasis; 11. Allergic to taxanes; 12. Pregnant or lactating women; 13. The investigators think it is not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
PFS;ORR;

Secondary

MeasureTime frame
DCR;OS;

Countries

China

Contacts

Public ContactSun Yuping

Ji'nan Central Hospital

13370582181@163.com+86 13370582181

Outcome results

None listed

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