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

The Prognosis Study of Postoperative Non-small-cell Lung Cancer Patients Treated Precisely With the Integrated Traditional Chinese and Western Medicine Based on CTC Detection

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03269162

Enrollment

144

Registered

2017-08-31

Start date

2016-09-30

Completion date

2019-09-30

Last updated

2017-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC

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.

Interventions

DRUGJinfukang Koufuye

30ml per time, tid, po (d6-21, q21)

DRUGDocetaxel

75mg/m2,ivgtt 30mins, d1

DRUGPemetrexed

500mg/m2, ivgtt 30mins, d1

DRUGCisplatin

75mg/m2, ivgtt \>2h, d1

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026