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

NCT06315101 | Completed

• 1 other identifier: K-2023-092
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Unresectable Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Adverse Events assessment

  after 8 weeks of the initiation of Lenvatinib combined with Chinese Herbal Medicine

Study Arms (1)

Lenvatinib combined with Chinese Herbal Medicine

Drug: Chinese Herbal Medicine

Interventions

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.

Lenvatinib combined with Chinese Herbal Medicine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• at least 18 years old
• histologically confirmed HCC unsuitable for resection
• lenvatinib as first- or second-line therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangzhou University of Chinese Medicine: lead

Study Sites (1)

the First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510407, China

Location

Study Officials

• Suihui Li, postgraduate

  The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 18, 2024
• Study Start: September 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)