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

NCT03269162 | Unknown Phase 3 DMC

• 1 other identifier: SHDC12016114
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Jinfukang + Chemotherapy Group

EXPERIMENTAL

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

Chemotherapy Group

PLACEBO COMPARATOR

Drug: Docetaxel; Drug: Pemetrexed; Drug: Cisplatin

Interventions

Jinfukang Koufuye DRUG

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

Jinfukang + Chemotherapy Group

Docetaxel DRUG

75mg/m2,ivgtt 30mins, d1

Chemotherapy Group; Jinfukang + Chemotherapy Group

Pemetrexed DRUG

500mg/m2, ivgtt 30mins, d1

Chemotherapy Group; Jinfukang + Chemotherapy Group

Cisplatin DRUG

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

Chemotherapy Group; Jinfukang + Chemotherapy Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathology-confirmed diagnosis of primary NSCLC with complete resection, and stage IB-IIB
• Accept chemotherapy for the first time 6 weeks after operation
• Age of 18-75 years old
• Eastern Cooperative Oncology Group-PS≤2
• N\>1.5×109/L、PLT\> 100 × 109/L、Hb\>100g/dL、Liver and kidney function is normal or elevated ≤ 1.5 times
• Voluntary participation in the prospective study with signed informed consent

You may not qualify if:

• No pathology-confirmed diagnosis patients
• Patients with overall survival time\<6 months
• Patients with Serious diseases like heart、liver、kidney and hematopoietic system at the same time
• Pregnant or breast feeding patients
• Patients with uncontrollable mentally disease
• Patients with diabetes

Sponsors & Collaborators

• lihegen: lead

MeSH Terms

Interventions

Docetaxel; Pemetrexed; Cisplatin

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Hegen Li

  Longhua Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Oncology Department Longhua Hospital

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: August 31, 2017
• Study Start: September 30, 2016
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: September 14, 2017

Record last verified: 2017-09