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NCT Number: NCT06315101

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

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

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Key information

Conditions

Unresectable Hepatocellular Carcinoma

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510407, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chinese herbal medicine

Drug

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.

Primary outcomes

  1. Efficacy outcomes

    Time frame: 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)

  2. Survival analysis

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

    Kaplan-Meier estimates of overall survival (OS)

  3. Survival analysis

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

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

Secondary outcomes

  1. Adverse Events assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Guangzhou University of Chinese Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 18, 2024
Registry last updated
Mar 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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