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

• Status: Unknown status
• Trial end date: 2019-09-30
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: lihegen
• Treatments: Docetaxel; Pemetrexed

Criteria

Inclusion Criteria:

1. Pathology-confirmed diagnosis of primary NSCLC with complete resection, and stage IB-IIB

2. Accept chemotherapy for the first time 6 weeks after operation

3. Age of 18-75 years old

4. Eastern Cooperative Oncology Group-PS≤2

5. N>1.5×109/L、PLT> 100 × 109/L、Hb>100g/dL、Liver and kidney function is normal or elevated ≤ 1.5 times

6. Voluntary participation in the prospective study with signed informed consent

Exclusion Criteria:

1. No pathology-confirmed diagnosis patients

2. Patients with overall survival time<6 months

3. Patients with Serious diseases like heart、liver、kidney and hematopoietic system at the same time

4. Pregnant or breast feeding patients

5. Patients with uncontrollable mentally disease

6. Patients with diabetes