Status:
UNKNOWN
The Efficacy and Drug Resistance Molecular Biology of Apatinib Combined With EGFR-TK1 Treated for Advanced Slow-progressed Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Beijing Chest Hospital
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Patients with advanced non-small cell lung cancer (NSCLC) who progress slowly after Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors（EGFR-TKI）resistance. The purpose of this study is to inv...
Detailed Description
Epidermal growth factor receptor Tyrosine kinase inhibitor (EGFR TKI) have been approved to treat NSCLC harboring EGFR mutation as first-line therapy. However, a large proportion of patients would bec...
Eligibility Criteria
Inclusion
- Informed consent should be obtained before treatment. Patients with good compliance.
- Histologically or cytologically confirmed IIIB/IV NSCLC.
- Progress in the treatment of EGFR TKI.
- Aged from 18 to 75 years (18 and 75 years are included); Gender Not Required.
- ECOG PS 0-1.
- Life expectancy ≥ 3 months.
- At least one measurable lesion (meet the requirements of the standard Response Evaluation Criteria In Solid Tumors (RESCIST) version 1.1). If the lesions that have received local treatment (radiation, radiofrequency, intervention, etc.) are the only lesions, it is required to have clear imaging progress.
Exclusion
- Uncontrolled hypertension (systolic ≥140mmHg and/or diastolic ≥90mmHg after medication treatment); Poor control of blood sugar.
- Acute phase of cerebral infarction, or recovery period \<2 months.
- A variety of factors that affect the absorption of oral medications (such as inability to swallow, nausea and vomiting, chronic diarrhea, intestinal obstruction, etc.)
- Patients with a risk of gastrointestinal bleeding may not be enrolled, including the following: (1) active digestive ulcer lesions, and fecal occult blood (++); (2) a history of melena and hematemesis within 2 months. Simple fecal occult blood (+) is not an exclusion criterion.
- Coagulation abnormality (INR\>1.5×ULN, APTT\>1.5×ULN), with bleeding tendency.
- Urine protein ≥ ++ or confirmed 24-hour urine protein quantitation \> 1.0 g.
- Pregnant or lactating women.
- Severe liver and kidney dysfunction (grade 4) .
- Allergic to any ingredient of apatinib mesylate.
- A history of abuse of psychotropic substances and are unable to quit smoking or mental disorders.
- According to the investigator's judgment, people with concomitant diseases that seriously endanger the safety of the patient or affect the patient's completion of the study.
- Surgery, major trauma or fracture, within 4 weeks before the treatment or unhealed wound before treatment.
- Severe heart disease, such as grade III or above (NYHA standard) congestive heart failure, grade III or above (CCS standard) angina, a history of myocardial infarction within 6 months before the treatment, or medication treated arrhythmia.
- Brain metastasis and meningeal metastasis.
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03811054
Start Date
December 1 2018
End Date
December 1 2020
Last Update
January 22 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Beijing Chest Hospital
Beijing, China