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

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

Study Overview

• Status: Completed
• Conditions: Unresectable Hepatocellular Carcinoma
• Intervention / Treatment: Drug: Chinese Herbal Medicine

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 Type: Observational
• Enrollment (Actual): 142

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510407
      • The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

In this retrospective cohort study, we collected data on consecutive patients with unresectable hepatocellular carcinoma from the electronic medical records at the First Affiliated Hospital of Guangzhou University of Chinese Medicine in China, covering the period from September 2018 to July 2022, and conducted follow-ups until May 30, 2023. All cases underwent lenvatinib combined with CHM as first-line therapy, with or without PD-1 inhibitors.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Lenvatinib combined with Chinese Herbal Medicine

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Survival analysis	Kaplan-Meier estimates of overall survival (OS)	2022/10/01-2023/12/31
Survival analysis	Kaplan-Meier estimates of progression-free survival (PFS)	2022/10/01-2023/12/31

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Guangzhou University of Chinese Medicine
• Investigators: Study Director: Suihui Li, postgraduate, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 7, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: K-2023-092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No