Clinical Study for Sequential Chemotherapy with Apatinib in Patients with Non-small Cell Lung Cancer
- Conditions
- lung cancer
- Registration Number
- ITMCTR1900002435
- Lead Sponsor
- Shanxi Provincial Hospital of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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: TBIL<1.5*ULN, ALT and AST<2.5*ULN, and < 5*ULN for liver metastasis patients, serum Cr=1.25 ULN or creatinine clearance >45ml/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.
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)
Study & Design
- Study Type
- Observational study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival;
- Secondary Outcome Measures
Name Time Method Disease Control Rate;Safety;Overall Survival;Quality of life score;Objective Remission Rate;