MedTrace Logo

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

NCT03269162 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2017-09-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Jinfukang Koufuye

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

DRUG

Docetaxel

75mg/m2,ivgtt 30mins, d1

DRUG

Pemetrexed

500mg/m2, ivgtt 30mins, d1

DRUG

Cisplatin

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

Sponsors & Collaborators

  • lihegen

    lead OTHER

Principal Investigators

  • Hegen Li · Longhua Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03269162 on ClinicalTrials.gov