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Clinical trial

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

ID
Name
K-2023-092
Description
This study aims to assess the effectiveness and safety of lenvatinib plus Chinese Herbal Medicine (CHM) for patients with uHCC in China.
Trial arms
Trial start
2023-09-01
Estimated PCD
2023-12-31
Trial end
2023-12-31
Status
Completed
Treatment
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.
Arms:
Lenvatinib combined with Chinese Herbal Medicine
Size
142
Primary endpoint
Efficacy outcomes
after 8 weeks of the initiation of Lenvatinib combined with Chinese Herbal Medicine
Survival analysis
2022/10/01-2023/12/31
Survival analysis
2022/10/01-2023/12/31
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 142, 'type': 'ACTUAL'}}
Updated at
2024-03-18

1 organization

1 product

1 indication

Organization
Guangzhou University of Chinese Medicine
Product
Chinese Herbal Medicine
Indication
Hepatocellular Carcinoma