NCT06315101

Effectiveness and Safety of Lenvatinib Combined With Chinese Herbal Medicine for Patients With Unresectable Hepatocellular Carcinoma: A Real-world Study in China

A Real-world Study of Lenvatinib Combined With Chinese Herbal Medicine for Patients With Unresectable Hepatocellular Carcinoma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 142 (actual)
• Sponsor: Guangzhou University of Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Unresectable Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Chinese Herbal Medicine	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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2024-03-18
• Last updated: 2024-03-18

Locations

1 site across 1 country: China