Objective: To study the effect of Jinfukang Koufuye combined with chemotherapy on preventing relapse and metastasis of early postoperative NSCLC patients. Method: In this multicenter、prospective、randomized controlled clinical trial, 144 NSCLC patients with complete resection、stage Ib-IIb were randomly divided into Jinfukang Koufuye combined with chemotherapy group (treatment group, N=72) and chemotherapy only group (controlled group, N=72). Peripheral blood CTCs and immune cells were detect on five different time points: after operation、4 chemotherapy cycles were over、12 months after operation、18 months after operation、and 24 months after operation. To evaluate the effect of Jinfukang Koufuye combined with chemotherapy on the level of peripheral blood CTCs、DFS、immune function、quality of life of postoperative patients; and decreasing the side effect of chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
144
30ml per time, tid, po (d6-21, q21)
75mg/m2,ivgtt 30mins, d1
500mg/m2, ivgtt 30mins, d1
75mg/m2, ivgtt \>2h, d1
Disease-free survival Rate
From the very beginning of the randomization to the end point when disease relapse or death because of any reason
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.