Advanced non-small cell lung cancer
Conditions
Interventions
Group 1:Xiaoyan Granule combined with Apatinib Mesylas
Group 2:Apatinib Mesylas
Sponsors
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years old to 75 years old, male or female; 2. The histological and / or cytological diagnosis of advanced non-small cell lung cancer; 3. surgery and / or radiotherapy and chemotherapy treatment failed for advanced non-small cell lung cancer; 4. ECOG PS 0-2 minutes; 5. The patients with advanced non-small cell lung cancer were differentially diagnosed by traditional Chinese medicine as qi deficiency and toxic retention; Qi deficiency syndrome: fatigue, low voice, inappetence, enlarged tongue, weak pulse; Heat-toxicity symptoms: red face, fever, ulcerated boils swelling and pain, red tongue with yellow fur, large and full pulse; Blood stasis syndrome: rough skin, subcutaneous ecchymosis, pain in the same position, limb numbness,dark purplish tongue with ecchymosis, stagnant pulse, pulselessness or deep stringy slow pulse; 6. major organs functioning properly, meet the following requirements: (1) blood tests, subject to (not transfusion within 14 days): HB=90g/L; ANC =1.5×10^9/L; PLT =80×10^9/L; (2) biochemical tests must meet the following criteria: BIL <1.5 times the upper limit of normal (ULN); ALT and AST <2.5 × ULN; if liver metastases, the ALT and AST <5 × ULN; Serum Cr=1 × ULN, creatinine clearance rate =50ml / min (Cockcroft-Gault formula); 7. The expected survival =3 months; 8. The treating physician plans to use the APA imatinib mesylate tablets therapy; 9. The patient voluntarily joined the study, and informed consent (ICF); 10. Women of childbearing age must be enrolled in the 7 days before a pregnancy test (serum or urine) results were negative, and the voluntary during the observation period and after the last administration for Nepalese Apa sheet 8 weeks using appropriate methods of contraception; for men, surgical sterilization should be, or agreed during the observation period and after the last administration for Nepalese Apa sheet 8 weeks using appropriate methods of contraception.
Exclusion criteria
Exclusion criteria: 1. The last chemotherapy and/or targeted therapy was at least 4 weeks apart from the first apatinib treatment;The toxicity associated with past chemotherapy and/or radiotherapy is persistent; 2. Radiation therapy (except for limbs and brain) 3 months before baseline imaging examination; 3. Clinical significant hemoptysis (greater than 1 teaspoon per day) has appeared in the past 3 months; 4. Suffering from hypertension, the antihypertensive drug therapy can not be reduced to the normal range (systolic blood pressure> 140 mmHg / diastolic blood pressure> 90 mmHg), with =level II of coronary heart disease, arrhythmia (including QTc interval prolongation men> 450 ms, female> 470 ms) and heart failure; 5. With a variety of factors influence oral absorption (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction); 6. Special Note: The patient has a risk of gastrointestinal bleeding can not be enrolled, including the following: (1) with active peptic ulcer lesions and fecal occult blood (+); black stools (2) 3 months, vomiting a history; (3) for fecal occult blood (+) - and the primary gastric tumor lesions did not undergo surgery, the need for endoscopy, such as gastric ulcer, and the treating physician believes it may cause bleeding lesions; 7. coagulopathy (INR> 1.5 × ULN, APTT> 1.5 × ULN), have bleeding tendencies; 8. Increase the risk associated with participating in the study or the study drug, and, according to the researchers' judgment, may lead to serious diseases or non-tumor syndrom that are not suitable for paeticipated in the study; 9. Patients cant appliance the test scheme; 10. Allergic reactions to contrast media; 11. Other treating physicians considered unsuitable for patients included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;The rate of advers reactions;ORR;DCR; | — |
Countries
China
Contacts
Public ContactJia Yingjie
First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed