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

lihegen

Status and phase: Unknown; Phase 3

Conditions: NSCLC

Treatments: Drug: Docetaxel; Drug: Pemetrexed; Drug: Cisplatin; Drug: Jinfukang Koufuye

Study type: Interventional

Funder types: Other

Identifiers

NCT03269162

SHDC12016114

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups, including a placebo group

Jinfukang + Chemotherapy Group

Experimental group

Treatment:

Drug: Cisplatin

Drug: Jinfukang Koufuye

Drug: Pemetrexed

Drug: Docetaxel

Chemotherapy Group

Placebo Comparator group

Treatment:

Drug: Cisplatin

Drug: Pemetrexed

Drug: Docetaxel