Long-Term Survival With Lenvatinib-Based Therapy in Unresectable Liver Cancer (NCT07298538) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Long-Term Survival With Lenvatinib-Based Therapy in Unresectable Liver Cancer
China800 participantsStarted 2019-01-01
Plain-language summary
This study reviewed real-world outcomes of patients with unresectable hepatocellular carcinoma who received lenvatinib-based treatment. The study evaluated long-term survival, treatment response, and safety using data collected from six hospitals.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* ≥ 18 years of age
* Patients with histologically or radiologically confirmed HCC who were newly diagnosed between January 2019 and December 2022 (meeting the diagnostic criteria of the American Association for the Study of Liver Diseases or the Chinese Guidelines for the Diagnosis and Treatment of Primary Liver Cancer).
* Patients with at least 1 measurable lesion in the liver per RECIST v.1.1.
* Initially unresectable HCC as determined by the investigator (including oncologically unresectable, surgically unresectable, or both).
* Child Pugh score ≤ 7
* ECOG-PS 0-1
* Patients who had not received any previous systemic therapy before receiving dual therapy (lenvatinib + immunotherapy/local therapy) or triple therapy (lenvatinib + immunotherapy + local therapy) as the first-line therapy. Combination therapy is defined as the initiation of immunotherapy or local therapy within 30 days (before or after) of the first dose of lenvatinib.
* Patients who had basic image data (CT/MRI/PET) and underwent at least one imaging evaluation during the systemic therapy (if the image data was obtained from other hospitals, the original data shall be provided for re-evaluation).
Exclusion Criteria:
* Patients with no overall survival (OS) endpoint observed, and a follow-up period after treatment initiation of less than 6 months.
* Patients with a pathological diagnosis of combined hepatocellular and intrahepatic cholangiocarcinoma (cHCC-ICC), cholangiocarcinoma, or othe…
What they're measuring
1
3-year Overall Survival Rate Estimated by Kaplan-Meier Method
Timeframe: 3 years after treatment initiation
Trial details
NCT IDNCT07298538
SponsorTianjin Medical University Cancer Institute and Hospital