Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 10, 2024
Date Accepted: Aug 25, 2025
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Efficacy of Fuzheng Quxie Formula against postoperative metastasis of lung cancer in stage IIA-IIIA with negative driver genes: study protocol for a multi-centre, double-blind, randomized controlled trial
ABSTRACT
Background:
Metastasis is the main reason for poor prognosis and high mortality of lung cancer. Surgery and postoperative adjuvant chemotherapy are the first choice for patients with negative driver genes in stage I to IIIA lung cancer. However, the recurrence rate after surgery did not significantly decrease. In China, traditional Chinese medicine (TCM) is commonly used to treat cancer. TCM has the potential to be used as an adjuvant therapy for lung cancer to reduce treatment related toxicity and improve the clinical efficacy.
Objective:
In view of the positive results of the basic study of Fuzheng Quxie Formula against lung cancer metastasis, we plan to evaluate the efficacy of Fuzheng Quxie Formula against postoperative metastasis of lung cancer in stage IIA-IIIA that is negative for driver gene expression.
Methods:
A multi-centre, double-blind, randomised, placebo-controlled parallel group controlled trial will be conducted. Eligible patients will be randomised into a treatment group (daily Fuzheng Quxie Formula granules + regular chemotherapy) and a control group (daily Chinese medicine placebo granules + regular chemotherapy) in a ratio of 1:1. Fuzheng Quxie Formula was administered orally, twice a day, in the morning and evening, for 6 months. Follow-up after the end of medication, follow-up period of 18 months. After the end of the programme, follow-up was continued until 5 years or until the subject died (or progressed). The primary outcome was disease-free survival (DFS), and the secondary outcomes were overall survival (OS), minimal residual disease (MRD), circulating tumour cell assay, chinese medicine symptom score, quality of life assessment (QoL), immune indicators, tumour markers, peripheral blood systemic immune- inflammation index (SII) and prognostic nutritional index (PNI).
Results:
This will be the first trial to evaluate the efficacy and safety of Fuzheng Quxie Formula in inhibitting metastasis after surgery in stage IIA-IIIA lung cancer with negative driver genes.
Conclusions:
This will be the first trial to evaluate the efficacy and safety of Fuzheng Quxie Formula in inhibitting metastasis after surgery in stage IIA-IIIA lung cancer with negative driver genes. Clinical Trial: Ethics and Dissemination: The Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine approved the study protocol (approval no.: 2023SHL-KY-19-01, 2023/03/01). Trial Registration: ClinicalTrials.gov NCT06381960.
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