Unresectable Hepatocellular Carcinoma
Conditions
Brief summary
This study aims to assess the effectiveness and safety of lenvatinib plus Chinese Herbal Medicine (CHM) for patients with uHCC in China.
Detailed description
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.
Interventions
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.
Sponsors
Guangzhou University of Chinese Medicine
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* at least 18 years old * histologically confirmed HCC unsuitable for resection * lenvatinib as first- or second-line therapy
Exclusion criteria
* patients with other primary tumors * patients who had only one visit record and were lost to follow-up or refused follow-up * patients with any other factors affecting study data collection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy outcomes | after 8 weeks of the initiation of Lenvatinib combined with Chinese Herbal Medicine | Tumor Response after 8 weeks of treatment according to the modified Response Evaluation Criteria in Solid Tumor (mRECIST) |
| Survival analysis | 2022/10/01-2023/12/31 | Kaplan-Meier estimates of overall survival (OS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events assessment | after 8 weeks of the initiation of Lenvatinib combined with Chinese Herbal Medicine | Adverse Events (AEs) were assessed following the guidelines of the Common Terminology Criteria for Adverse Events version 4.0. |
Countries
China
Outcome results
None listed