Clinical Study of Chinese Medicine Plus Targeted Therapy Maintenance in Advanced Pulmonary Adenocarcinoma
Cancer
About this trial
This is an interventional treatment trial for Cancer focused on measuring lung cancer, traditional Chinese medicine, maintenance therapy, targeted therapy
Eligibility Criteria
Inclusion Criteria:
- Pathologically or cytologically confirmed of stage IIIa-IV pulmonary adenocarcinoma;
- The efficacy evaluation of the first-line therapy is progression-free including complete response(CR), partial response(PR) and stable disease(SD);
- Age ≥18 years old;
- Physical status score (ECOG PS) ≤ 2 scores;
- Estimated life expectancy of at least 12 weeks;
- Participants have no major organ dysfunction: hemoglobin ≥9 g/dL, absolute neutrophil count (ANC) ≥1.5*109/L, platelets ≥100 *109/L,bilirubin ≤1.5ULN, alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 upper limited number(ULN) (AP, AST, ALT ≤5ULN is acceptable if liver has tumor involvement).INR≤1.5, APTT in the normal range( 1.2DLN-1.2ULN),creatinine ≤1.5ULN;
- Planning for targeted maintenance.
- Informed consent from the patient.
Exclusion Criteria:
- The efficacy evaluation of the first-line therapy is progressive disease(PD);
- Patient with other malignant tumor except NSCLC 5 years previous to study entry;
- Patient has already received chemotherapy or other anticancer treatment;
- Estimated life expectancy less than 12 weeks;
- Brain metastasis (controlled brain metastasis and steroid free need is excluded);
- History of cardiovascular disease: Congestive Heart Failure > grade II in NYHA.Unstable angina patients (have angina symptoms in rest) or a new occurrence of angina (began in the last 3 months) or myocardial infarction happens in the last 6 months;
- Pregnant or child breast feeding women;
- Mental or cognitive disorders;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
TCM granules plus EGFR-TKIs
Placebo granules plus EGFR-TKIs
TCM granules: oral granules, "YiQiFang" or "YangYinFang" or "YiQiYangYinFang", four packages, twice a day, until progression or unacceptable toxicity; EGFR-TKIs: oral tablet, Gefitinib® 250mg daily or Erlotinib® 150mg daily or Icotinib® 125 mg three times a day,until progression or unacceptable toxicity.
Placebo granules: oral granules, which the taste and smell are similar to experimental TCM granules and has no therapeutic effect, four packages, twice a day, until progression or unacceptable toxicity; EGFR-TKIs: oral tablet, Gefitinib® 250mg daily or Erlotinib® 150mg daily or Icotinib® 125 mg three times a day until progression or unacceptable toxicity.