advanced lung adenocarcinoma with EGFR-sensitive mutation
Conditions
Interventions
combined group:Thalidomide+Gefitinib
single drug group:Gefitinib
Sponsors
Fujian Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. more than 18 years old; 2. cytologically or histologically proven diagnosis of lung adenocarcinoma; 3. stage IV according to American Joint Committee on Cancer (AJCC); 4. EGFR exon 19 deletion or 21 L858R mutation; 5. ECOG score 0-3; 6. at least one target tumor lesion can be measured by CT or MRI(the long diameter of tumor lesion=10mm, the short diameter of lymph node lesions=15mm and the target lesions not be treated with radiotherapy or freezing and so on); 7. life expectancy more than 12 weeks; 8. first-line treatment, no prior chemotherapy, other targeted therapy and immunotherapy (postoperative adjuvant therapy must be completed=6 months); 9. radiotherapy must be completed=4 weeks and the acute toxicities must been restored; previous radiotherapy lesion cannot be target tumor lesion unless progress; 10. the major organs function are normal: ANC= 1.5×10^9/L, PLT=100×10^9/L, Hb=100g/L; TBIL <1.5×ULN, ALT and AST <2.5×ULN, BUN and Cr=1 x ULN; 11. Patients with uncontrollable or symptomatic brain metastasis cannot be enrolled in the group; 12. follow research requirements and follow-up procedures, signed informed consent form; 13. Women of childbearing age must contraception (such as IUDs, contraceptives or condoms) during the study period and 6 months after the end of the of study; blood or urine pregnancy tests negative 7 days prior to study enrollment and to be Non-lactating patients; men must contraception during the study period and within six months after the end of the study.
Exclusion criteria
Exclusion criteria: 1. serious violation of the inclusion criteria; 2. can not follow the research requirements and follow-up procedures; 3. previously used Gefitinib or Thalidomide; 4. allergic to Gefitinib or Thalidomide; 5. arterial/venous thromboembolism within 6 monthssuch ascerebrovasular accident (transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, pulmonary embolism and so on; 6. hereditary or acquired bleeding and thrombophilia (hemophilia, coagulopathy,thrombocytopenia, hypersplenism and so on); 7. coagulation abnormalities (INR>1.5 or PT>ULN+4s or APTT>1.5ULN) ,bleeding tendency or receiving thrombolysis or anticoagulant therapy; 8. having or previously have pulmonary interstitial disease; 9. have variouse factors that affect the oral medication (can not swallow, after gastrointestinal resection, chronic diarrhea and intestinal obstruction and so on); 10. with severe and / or uncontrollable disease; 11. Mentally disabled; 12. pregnant or lactating women; unwilling or unable to contraceptive measures; 13. attendant diseases that have a serious impact on patient safety or affect the patient's completion of the study; 14. other situations that may affect the conduct of clinical research and the findings of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the objective response rates, ORR;progression free survival, PFS; | — |
Countries
China
Contacts
Public ContactZhuang Wu
Fujian Provincial Cancer Hospital
Outcome results
None listed