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This study aims to assess the effectiveness and safety of lenvatinib plus Chinese Herbal Medicine (CHM) for patients with uHCC in China.
Liver resection is one of the most important treatments for hepatocellular carcinoma (HCC). However, only a minority of patients have the opportunity to undergo surgery. The development of systemic therapy has dramatically changed the management of unresectable HCC (uHCC). And lenvatinib garners a recommendation as the primary treatment for uHCC. Many patients with uHCC in Asian countries seek complementary and alternative therapies with traditional Chinese medicine (TCM). However, the impact of lenvatinib combined with CHM on uHCC patients remains unclear. In this study, we conducted a retrospective cohort study to assess the effectiveness and safety of lenvatinib plus CHM for patients with uHCC in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenvatinib combined with Chinese Herbal Medicine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chinese Herbal Medicine | Drug | Patients were treated with Chinese herbal medicine (CHM). CHM refers to the administration of a syndrome-specific herbal formula prescribed by a Traditional Chinese Medicine (TCM) physician after an uHCC diagnosis. Physicians determine the formula based on tongue and pulse examinations and personalized TCM syndromes derived from individual patient symptoms, adhering to established therapeutic principles and long-term clinical experience of physicians. The CHM formula applied in the study followed overarching TCM strategies, including reinforcing spleen qi, harmonizing liver qi, addressing blood stasis, and detoxification. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy outcomes | Tumor Response after 8 weeks of treatment according to the modified Response Evaluation Criteria in Solid Tumor (mRECIST) | after 8 weeks of the initiation of Lenvatinib combined with Chinese Herbal Medicine |
| Survival analysis | Kaplan-Meier estimates of overall survival (OS) | 2022/10/01-2023/12/31 |
| Survival analysis | Kaplan-Meier estimates of progression-free survival (PFS) | 2022/10/01-2023/12/31 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events assessment | Adverse Events (AEs) were assessed following the guidelines of the Common Terminology Criteria for Adverse Events version 4.0. | after 8 weeks of the initiation of Lenvatinib combined with Chinese Herbal Medicine |
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Inclusion Criteria:
Exclusion Criteria:
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In this retrospective cohort study, we collected data on consecutive patients with unresectable hepatocellular carcinoma from the electronic medical records at the First Affiliated Hospital of Guangzhou University of Chinese Medicine in China, covering the period from September 2018 to July 2022, and conducted follow-ups until May 30, 2023. All cases underwent lenvatinib combined with CHM as first-line therapy, with or without PD-1 inhibitors.
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| Name | Affiliation | Role |
|---|---|---|
| Suihui Li, postgraduate | The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Guangzhou University of Chinese Medicine | Guangzhou | Guangdong | 510407 | China |
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