What question did this study set out to answer?

This study aims to assess the efficacy and safety of comprehensive Traditional Chinese Medicine as an adjuvant treatment for resected non-small cell lung cancer.

April 13, 2026Open Access

Clinical efficacy of comprehensive traditional Chinese medicine in adjuvant therapy for stage Ib-IIIa resected non-small cell lung cancer: a multi-center, randomized, double-blind, placebo-controlled trial

Key Points

This study aims to assess the efficacy and safety of comprehensive Traditional Chinese Medicine as an adjuvant treatment for resected non-small cell lung cancer.
Conducted as a multi-center, randomized, double-blind, placebo-controlled trial.
Involved 286 participants with fully resected stage IB-IIIA NSCLC.
Participants were randomly assigned to receive TCM granules plus chemotherapy or placebo granules plus chemotherapy.
Included four cycles of chemotherapy followed by four cycles of Huachansu injections.
The TCM treatment group showed a 65.70% disease-free survival rate compared to 55.4% in the control group.
Median disease-free survival was 37.8 months for TCM compared to 31.6 months for the control group, with a significant hazard ratio of 0.73 (p = 0.045).
TCM granules improved symptoms like fatigue, pain, and insomnia, enhancing overall quality of life without unexpected adverse events.

Abstract

Background Recurrence and metastasis after radical resection for non-small cell lung cancer (NSCLC) remain a significant cause of treatment failure. Comprehensive Traditional Chinese Medicine (TCM) has emerged as a vital therapeutic approach in China. This study evaluated the efficacy and safety of TCM treatment with platinum-based adjuvant chemotherapy for patients of stage IB-IIIA resected NSCLC. Methods A randomised controlled trial was conducted at four centres in Shanghai, China. A total of 286 participants with completely resected (R0) stage IB-IIIA NSCLC were randomly divided in a 1:1 ratio to a TCM treatment group (n = 143) and a control group (n = 143). Which received adjuvant chemotherapy plus TCM granules or placebo granules, for four cycles. And then, followed by four cycles of Huachansu injections. The received in addition to the adjuvant chemotherapy, followed by placebo injections. Results ITT analysis was concluded with 286 patients. 2-year disease-free survival (DFS) rate (95% Confidence Interval CI) was 65.70% (57.86, 73.54) in the TCM treatment group and was 55.4% (47.17, 63.63) in the control group, the difference was not statistically significant, but a trend was observed (p = 0.08). A significantly prolonged DFS in the TCM group was revealed in contrast to the control group (37.8 months vs. 31.6 months, Hazard Ratio HR, 0.73; 95% CI 0.579, 0.995; p = 0.045). TCM granules significantly improved lung cancer-related symptoms including fatigue, pain, dyspnea, insomnia, cough, chest pain and diarrhea, and promote physical function, emotional function and overall health. No unexpected treatment-related adverse events were observed in both groups. Conclusion Comprehensive Traditional Chinese Medicine treatment combined with chemotherapy-based adjuvant therapy have a positive impact on DFS and improved quality of life in NSCLC patients. These findings suggested that TCM can be used as one of the adjuvant therapies following unselected radical resection in Chinese patients with stage IB-IIIA NSCLC. Clinical Trial Registration https://www.chictr.org.cn/ , identifier ChiCTR-IPR-16009062.

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