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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03269162
Other study ID # SHDC12016114
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received August 18, 2017
Last updated September 13, 2017
Start date September 30, 2016
Est. completion date September 30, 2019

Study information

Verified date September 2017
Source Shanghai University of Traditional Chinese Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 144
Est. completion date September 30, 2019
Est. primary completion date September 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Jinfukang Koufuye
30ml per time, tid, po (d6-21, q21)
Docetaxel
75mg/m2,ivgtt 30mins, d1
Pemetrexed
500mg/m2, ivgtt 30mins, d1
Cisplatin
75mg/m2, ivgtt >2h, d1

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
lihegen

Outcome

Type Measure Description Time frame Safety issue
Primary Disease-free survival Rate From the very beginning of the randomization to the end point when disease relapse or death because of any reason 2 years
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