Clinical Study of YYJD Decoction Combined With Gefitinib in Advanced Pulmonary Adenocarcinoma

Launched by SHANGHAI UNIVERSITY OF TRADITIONAL CHINESE MEDICINE · Oct 8, 2016

Keywords

ClinConnect Summary

Non-Small-Cell Lung Cancer（NSCLC）is one of the malignancies with high incidence and mortality. Epidermal growth factor receptor (EGFR) is implicated in NSCLC pathogenesis. Certain patient subgroups with NSCLC (ie, women, never-smokers, East Asians,adenocarcinoma) have higher rates of EGFR mutations, rendering them more responsive to EGFR tyrosine kinase inhibitors (TKIs; eg, gefitinib, erlotinib, Icotinib). Among patients with advanced EGFR-mutated NSCLC, treatment with EGFR-TKIs is associated with response rates of 56 to 74% and a median progression-free survival(mPFS) of 10 to 14 months;b...

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Eligibility criteria

• Inclusion Criteria:
• • Pathologically or cytologically confirmed stage IIIa-IV pulmonary adenocarcinoma;
• • With activating EGFR mutation (either exon19del or exon21L858R) and one month of gefitinib as first-line or second-line therapy without disease progression (PD);
• • With TCM diagnostic pattern Qin-and-yin dificiency;
• • Age ≥18 years old;
• • Estimated life expectancy of at least 12 weeks;
• • Without 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 with liver metastasis).INR≤1.5, APTT in the normal range( 1.2DLN-1.2ULN),creatinine ≤1.5ULN;
• Exclusion Criteria:
• • with other malignant tumor except NSCLC 5 years previous to study entry;
• • PD after onee month of gefitinib treatment
• • Estimated life expectancy less than 12 weeks;
• • Brain metastasis with relevant symptoms
• • 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;