lung cancer
Conditions
Sponsors
Shanxi Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. advanced NSCLC (IIIB, IV) confirmed by pathology, with second-line or above who have failed first-line standard platinum-containing dual-drug chemotherapy, with lung adenocarcinoma without sensitive mutation or TKI drug resistance,with measurable lesions (CT scan Long diameter of tumor=10mm, CT scan Long diameter of lymph node lesion=15mm,scan slice thickness>5mm); 2. aged 18-75 years male and female; 3. Estimated survival time=3 mouths; 4. ECOG 0-2; 5. Damage caused by other treatments has been recovered (NCI-CT CAE version 4.0 grade = 1 grade); 6. The main organ function is normal, and meet the following standards(patients has not using blood transfusion , blood products or GCF and other correction of hematopoietic stimulating factor within 14 days): (1) The standard of blood routine examination should be consistent: HB=90 g/L, ANC=1.5×10^9/L, PLT=80×10^9/L; (2) Biochemical tests should meet the following criteria: TBIL45ml/min; 7. Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib. For man, surgical sterilization should be performed, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib; 8. Patients voluntarily entered the study and signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Toxicity of chemotherapy or radiotherapy related clinical treatment has persisted; 2. Radiological evidence (CT or MRI) shows that there is a central tumor invading local large vessels; 3. Clinically significant hemoptysis within last 3 months(hemoptysis is more than 1 teaspoon per day); 4. Accepted anticoagulant(except low-dose heparin) or DaPT; 5. Serious thrombus or clinically associated severe bleeding event within last 6 months; 6. The target lesion received radiotherapy and freezing within 3 months; 7. Severe trauma and/or surgery occurred within 10 days before random grouping, and wound healing was incomplete; 8. Severe infection requiring systemic antibiotic treatment; 9. Gastrointestinal diseases or abnormalities that may interfere with drug absorption; 10. active or chronic hepatitis C and/or hepatitis B infection; 11. Pregnant or breastfeeding, unwilling to use medically acceptable contraceptive measures during the trial and at least 12 months after the end of drug therapy; 12. High blood pressure and failure to be reduced to normal range by antihypertensive drugs(Systolic pressure > 140 mmHg, diastolic pressure >90mmHg)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Safety;Overall Survival;Quality of life score;Objective Remission Rate; | — |
Countries
China
Contacts
Public ContactLikun Liu
Shanxi Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed