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A prospective, non-intervention study of Apatinib in the treatment of advanced lungsquamous carcinoma

A prospective, non-intervention study of Apatinib in the treatment of advanced lungsquamous carcinoma

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-17012473
Enrollment
Unknown
Registered
2017-08-25
Start date
2017-10-15
Completion date
Unknown
Last updated
2017-09-04

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

Conditions

Lung Cancer

Interventions

Intervention:apatinib

Sponsors

The Second People's Hospital of Yibin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years; 2. ECOG score: 0-2; 3. The histopathologic or cytopathologic diagnosed IIIB or IV non-central lung squamous carcinoma ,including patients with predominantly squamous cell tumours ( i.e. >50% of squamous cells in the sample used for histological diagnosisby a pathologist); 4. At least one measurable lesions, and distance great vessels > 5 mm (in accordance with the requirements of RECIST 1.1 the measurable lesions spiral CT scan length to diameter 10 mm or swollen lymph nodes or short diameter 15 mm or higher); 5. After treatment failure of chemotherapy of patients with advanced lung squamous carcinoma; 6. Patients who are unwilling to undergo first-line chemotherapy after first diagnosis or unwilling to continue to undergo chemotherapy; 7. The blood routine examination should accord with a standard (no blood transfusion and adjuvant therapies within 14 days, unused and other hematopoietic stimulating factor (g-csf) correct): HB 80 g/L or higher; the ANC acuity 1.5*10^9/L; PLT acuity 80*10^9/L; 8. Biochemical examination must be in accordance with the following criteria: TBIL 45 ml/min; 9. Women of childbearing age should be carried out in the group of 7 days before the pregnancy test (serum), and the resul; 10. Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion criteria

Exclusion criteria: 1. Imaging (CT or MRI) shows signs of tumor invasion of large vessels, such as tumors that are completely close, wrapping or invading the lumen of the large vessels (such as the superior pulmonary artery or superior vena cava); 2. Radiological evidence suggests that there is empty or necrotic tumor; 3. Patients with EGFR, ALK or ROS1 gene sensitive mutations; 4. People with high blood pressure and antihypertensive drug therapy can not drop to normal range (systolic blood pressure = 140 mmHg, diastolic blood pressure = 90 mmHg); 5. Always suffer from severe cardiovascular disease: II magnitude of myocardial ischemia and myocardial infarction, poor control of cardiac arrhythmias (including QTc interphase male 450, female 470 ms or ms or higher); According to NYHA standard; 6. III~IV cardiac insufficiency, or heart colour to exceed revealed left ventricular ejection fraction (LVEF) 1.5, APTT ULN > 1.5), with bleeding tendency; 10. Patients who have significant effects on oral drug absorption (e.g., inability to swallow, frequent vomiting, etc); 11. The urine protein in patients with positive (+ 2 or more urinary protein detection, or 24 hours urinary protein quantitative > 1.0 g); 12. Other anti-angiogenic drugs (such as endostatin, bevacizumab) have been used within last 1 month; 13. Suffering from other untreated malignant tumors; 14. Pregnant or lactating women; 15. HIV positive, HCV positive, or RPR positive; 16. Patients with hepatitis B surface antigen (HBsAg) positive and peripheral blood of hepatitis B virus deoxyribonucleic acid (HBV DNA) titer over 1 * 103 copies /L; 17. Patients with contraindications, according to the drug manual; 18. Patients who are participating in other clinical trials; 19. Researchers think that patients don't suitable for this test.

Design outcomes

Primary

MeasureTime frame
PFS;Safety;

Secondary

MeasureTime frame
ORR;DCR;OS;

Countries

China

Contacts

Public ContactJia Yuming

The Second People's Hospital of Yibin

ybjqx3340@sina.com+86 13330663082

Outcome results

None listed

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