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

Phase 3

• Conditions: NSCLC
• Interventions: Drug: Jinfukang Koufuye; Drug: Docetaxel; Drug: Pemetrexed; Drug: Cisplatin

• Registration Number: NCT03269162
• Lead Sponsor: lihegen

Brief 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2016-09-30
• Study First Submitted: 2017-08-18
• Study First Submitted QC: 2017-08-29
• Study First Posted: 2017-08-31
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-13
• Last Update Posted: 2017-09-14
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Jinfukang + Chemotherapy Group	Jinfukang Koufuye	-
Jinfukang + Chemotherapy Group	Docetaxel	-
Jinfukang + Chemotherapy Group	Pemetrexed	-
Jinfukang + Chemotherapy Group	Cisplatin	-
Chemotherapy Group	Docetaxel	-
Chemotherapy Group	Pemetrexed	-
Chemotherapy Group	Cisplatin	-

Primary Outcome Measures

Name	Time	Method
Disease-free survival Rate	2 years	From the very beginning of the randomization to the end point when disease relapse or death because of any reason