Clinical trial NCT06315101: Effectiveness and Safety of Lenvatinib Combined With Chinese Herbal Medicine for Patients With Unresectable Hepatocellular Carcinoma: A Real-world Study in China
Official title: A Real-world Study of Lenvatinib Combined With Chinese Herbal Medicine for Patients With Unresectable Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unresectable Hepatocellular Carcinoma
Lead sponsor: Guangzhou University of Chinese Medicine
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy outcomes
timeFrame: after 8 weeks of the initiation of Lenvatinib combined with Chinese Herbal Medicine
measure: Survival analysis
timeFrame: 2022/10/01-2023/12/31
measure: Survival analysis
timeFrame: 2022/10/01-2023/12/31
Secondary outcomes:
measure: Adverse Events assessment
timeFrame: after 8 weeks of the initiation of Lenvatinib combined with Chinese Herbal Medicine
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the First Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
name: Suihui Li, postgraduate
role: STUDY_DIRECTOR
References: