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

• Status: Unknown status
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators performed a multi-centered, randomized, double blinded, placebo-controlled, prospective clinical trial on the effect of Yiqi-yangyin-jiedu decoction (YYJD), a chinese herbal medicine (CHM) formula combined with gefitinib to prolong the progression free survival (PFS) of advanced pulmonary adenocarcinoma patients with activating EGFR mutation (exon19del or exon21L858R). The investigators plan to enroll 198 cases in 3 years (99 cases for gefitinib, 99 cases for gefitinib plus YYJD), expecting that combination therapy has a better efficacy on prolonging PFS, overall survival, improving quality of life(QOL).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborators: Shanghai Chest Hospital; Shanghai Pulmonary Hospital, Shanghai, China
• Treatments: Gefitinib

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;