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

Unresectable Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06315101
• Other study ID #: K-2023-092
• Status: Completed
• Start date: September 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Guangzhou University of Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to assess the effectiveness and safety of lenvatinib plus Chinese Herbal Medicine (CHM) for patients with uHCC in China.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Unresectable Hepatocellular Carcinoma

Intervention

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.

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Guangzhou University of Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Survival analysis	Kaplan-Meier estimates of overall survival (OS)	2022/10/01-2023/12/31
Primary	Survival analysis	Kaplan-Meier estimates of progression-free survival (PFS)	2022/10/01-2023/12/31
Secondary	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