Efficacy of Fuzheng Quxie Formula Against Postoperative Metastasis of Lung Cancer in Stage IIA-IIIA With Negative Driver Genes: Protocol for a Multicenter, Double-Blind, Randomized Controlled Trial
Bibliographic record
Abstract
BACKGROUND: Metastasis is the primary cause of poor prognosis and high mortality in lung cancer. Surgery with postoperative adjuvant chemotherapy is the standard treatment for patients with stage IIA-IIIA lung cancer with negative driver genes. However, recurrence rates remain significant. In China, traditional Chinese medicine shows potential as an adjuvant therapy to reduce treatment toxicity and improve clinical efficacy. OBJECTIVE: This study aimed to evaluate its efficacy and safety in preventing postoperative metastasis in driver gene-negative stage IIA-IIIA lung cancer, based on the promising preclinical results of Fuzheng Quxie Formula against lung cancer metastasis. In this trial, we hypothesize that the treatment group will have better efficacy and safety than the control group. METHODS: A multicenter, double-blind, randomized, placebo-controlled parallel group trial will be conducted. Eligible patients will be randomized 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 will be administered orally, twice a day, in the morning and evening, for 6 months. Patients will be followed up after the end of treatment for 18 months. After the end of the program, follow-up will be continued for 5 years or until the patient dies (or progressed). The primary efficacy endpoint is disease-free survival, and the secondary efficacy endpoints are overall survival, minimal residual disease, circulating tumor cells, Chinese medicine symptom score, quality-of-life assessment, immune indicators, tumor markers, peripheral blood systemic immune-inflammation index, and prognostic nutritional index. We will conduct per-protocol analyses on these outcomes. In addition, we will also evaluate the safety of the Fuzheng Quxie Formula. RESULTS: This study began screening and recruitment in March 2023. Recruitment is ongoing; by the end of 2024, a total of 180 eligible participants will be enrolled. Recruitment will continue until the end of June 2025 or until the target sample is reached. We estimate that the results will be published by March 2026. CONCLUSIONS: This study is a high-quality, large-scale, multicenter, double-blind, randomized controlled trial. This will be the first trial to evaluate the efficacy and safety of Fuzheng Quxie Formula in inhibiting metastasis after surgery in stage IIA-IIIA lung cancer with negative driver genes. Provide a basis for the clinical application of Fuzheng Quxie Formula. TRIAL REGISTRATION: ClinicalTrials.gov NCT06381960; https://clinicaltrials.gov/study/NCT06381960. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/66342.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.018 | 0.016 |
| Meta-epidemiology (narrow) | 0.006 | 0.002 |
| Meta-epidemiology (broad) | 0.011 | 0.005 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.003 | 0.003 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.003 | 0.001 |
| Research integrity | 0.007 | 0.006 |
| Insufficient payload (model declined to judge) | 0.031 | 0.005 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".