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

Guangzhou University of Chinese Medicine142 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

142

Conditions

Unresectable Hepatocellular Carcinoma

Interventions

Chinese Herbal MedicineDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

the First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Efficacy outcomes

Tumor Response after 8 weeks of treatment according to the modified Response Evaluation Criteria in Solid Tumor (mRECIST)

Time frame: after 8 weeks of the initiation of Lenvatinib combined with Chinese Herbal Medicine

Survival analysis

Kaplan-Meier estimates of overall survival (OS)

Time frame: 2022/10/01-2023/12/31

Survival analysis

Kaplan-Meier estimates of progression-free survival (PFS)

Time frame: 2022/10/01-2023/12/31

Secondary Outcomes

Adverse Events assessment

Adverse Events (AEs) were assessed following the guidelines of the Common Terminology Criteria for Adverse Events version 4.0.

Time frame: after 8 weeks of the initiation of Lenvatinib combined with Chinese Herbal Medicine

Data from ClinicalTrials.gov

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