Clinical trial · Interventional
Postoperative NSCLC Treated With Integrated Medicine Base on Circulating Tumor Cell Detection
The Prognosis Study of Postoperative Non-small-cell Lung Cancer Patients Treated Precisely With the Integrated Traditional Chinese and Western Medicine Based on CTC Detection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Jinfukang Koufuye | Drug | — | UNRESOLVED |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Jinfukang + Chemotherapy Group
- interventionNames
- Drug: Jinfukang Koufuye
- Drug: Docetaxel
- Drug: Pemetrexed
- Drug: Cisplatin
- type
- PLACEBO_COMPARATOR
- label
- Chemotherapy Group
- interventionNames
- Drug: Docetaxel
- Drug: Pemetrexed
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Disease-free survival Rate
- timeFrame
- 2 years
- description
- From the very beginning of the randomization to the end point when disease relapse or death because of any reason
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available