drugset / Trial / NCT03269162

Postoperative NSCLC Treated With Integrated Medicine Base on Circulating Tumor Cell Detection

NCT03269162

Phase 3 Unknown 144 enrolled lihegen
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2016-09-30
Primary completion
2019-09-30
Completion
2019-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject JinFuKang Traditional medicine (herbal / TCM) 30 ml Oral
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background Docetaxel Small molecule 75 mg/m2 Intravenous
Background Pemetrexed Small molecule 500 mg/m2 Intravenous