non-small cell lung cancer
Conditions
Interventions
taxus capsule for quamous cell carcinoma group:Taxus capsule
Pemetrexed for quamous cell carcinoma group:Pemetrexed
Taxus capsule for non-quamous cell carcinoma group:Taxus capsule
Gemcitabine for non-quamous cell carcinoma group:Gemcitabine
Sponsors
Guanganmen Hospital of Chinese Academy of traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The patients voluntarily participate in this study and sign the informed consent form; 2. The patients with Phase III or IV non-small cell lung cancer were initially diagnosed as not suitable for surgery by histopathology and/or cytology prior to enrollment. After treatment with 4-6 cycles of first-line chemotherapy, they were in stable conditions, and included within 1 month since the end of last chemotherapy cycle (= 31 days); 3. The patients in line with the standards of Chinese medicine on Qi deficiency phlegm stasis syndrome; 4. The patients at least with one measurable lesion on single diameter (RECIST standard version 1.1): the longest diameter of tumor lesions in CT or MRI scan images =10mm, the short diameter of lymph node lesions in CT scan image =15mm; 5. The results of laboratory tests must meet the following criteria: white blood cells =3.0×10^9/L, neutrophils =1.5×10^9/L, platelet =6×10^9/L, red blood cells =2×10^12/L, hemoglobin =8.0g/dl, total bilirubin =1.5 times normal upper limit, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =3.0 times normal upper limit, or for patients with liver cancer metastases, ALT and AST =5.0 times normal upper limit, and the total creatinine =1.5 times normal upper limit; 6. ECOG score =2, and expected survival more than 3 months; 7. Aged 18 to 80 years old (including 18 and 80 years old).
Exclusion criteria
Exclusion criteria: 1. Patients with symptomatic brain cancer metastases; 2. Patients with known EGFR sensitive mutations or ALK fusion gene positive to targeted drugs but willing to accept such treatment; 3. Patients suitable for surgical treatment after 4-6 cycles of first-line chemotherapy; 4. Patients intolerant to the treatment of this study drug due to the serious or uncontrolled organic lesions on heart, brain, liver, kidney and hematopoietic system, or serious complications and infection, fever, bleeding tendency; 5. Patients currently suffering from primary malignant tumors in other systems or organs; 6. Patients with serious mental illness, suspected or actual alcohol, drug abuse history; 7. Women in pregnancy, lactation or prepared for pregnancy currently; 8. Patients sensitive to drugs used in this study (eg, compound taxus capsule, Gemcitabine or Pemetrexed) or any of their ingredients; 9. Patients participating in other clinical research over the past three months; 10. Patients evaluated by researchers as not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to progression;Objective remission rate;Disease control rate;FACT-LQoL scale;MDASI-TCM scale; | — |
Countries
China
Contacts
Public ContactWei Hou
Guang'anmen Hospital, Chinese Academy of Chinese Medicine
Outcome results
None listed