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

Completed

• Conditions: Unresectable Hepatocellular Carcinoma
• Interventions: Drug: Chinese Herbal Medicine

• Registration Number: NCT06315101
• Lead Sponsor: Guangzhou University of Chinese Medicine

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.

Study Timeline

• Study Start: 2023-09-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Study First Submitted: 2024-03-07
• Study First Submitted QC: 2024-03-14
• Last Update Submitted: 2024-03-14
• Study First Posted: 2024-03-18
• Last Update Posted: 2024-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lenvatinib combined with Chinese Herbal Medicine	Chinese Herbal Medicine	-

Primary Outcome Measures

Name	Time	Method
Survival analysis	2022/10/01-2023/12/31	Kaplan-Meier estimates of progression-free survival (PFS)
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)

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

the First Affiliated Hospital of Guangzhou University of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China