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

NCT ID: NCT03269162

Last Updated: 2017-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-09-30

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.

Conditions

NSCLC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Jinfukang + Chemotherapy Group

Group Type: EXPERIMENTAL

Jinfukang Koufuye

Intervention Type: DRUG

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

Docetaxel

Intervention Type: DRUG

75mg/m2,ivgtt 30mins, d1

Pemetrexed

Intervention Type: DRUG

500mg/m2, ivgtt 30mins, d1

Cisplatin

Intervention Type: DRUG

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

Chemotherapy Group

Group Type: PLACEBO_COMPARATOR

Docetaxel

Intervention Type: DRUG

75mg/m2,ivgtt 30mins, d1

Pemetrexed

Intervention Type: DRUG

500mg/m2, ivgtt 30mins, d1

Cisplatin

Intervention Type: DRUG

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

Interventions

Jinfukang Koufuye

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

Intervention Type: DRUG

Docetaxel

75mg/m2,ivgtt 30mins, d1

Intervention Type: DRUG

Pemetrexed

500mg/m2, ivgtt 30mins, d1

Intervention Type: DRUG

Cisplatin

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

lihegen

OTHER

Sponsor Role: lead

Responsible Party

lihegen

Director of Oncology Department Longhua Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hegen Li

Role: PRINCIPAL_INVESTIGATOR

Longhua Hospital

Other Identifiers

SHDC12016114

Identifier Type: -

Identifier Source: org_study_id