Clinical Trials in China / NCT07298538
Active, not recruiting
Observational
Long-Term Survival With Lenvatinib-Based Therapy in Unresectable Liver Cancer
NCT07298538 · tracked via the Priya Life Science China tracker
Condition(s) studied
Unresectable Hepatocellular Carcinoma
Study 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.
Eligibility
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 other non-HCC malignant tumors.
* Patients with other inadequately treated malignant tumors previously or currently.
* Prior liver transplantation/hepatectomy/ablation for liver cancer.
Primary outcome measure(s)
- 3-year Overall Survival Rate Estimated by Kaplan-Meier Method — 3 years after treatment initiation
3-year cumulative survival rate estimated based on the Kaplan-Meier method
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | China |
More Tianjin Medical University Cancer Institute and Hospital trials in China
Other trials for the same condition
Atezolizumab Plus Bevacizumab Combined With Locoregional Therapies in Unresectable Hepatocellular Carcinoma (ISMIO-001)
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Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Treatment for Unresectable HCC
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Chinese HCC Efficacy Evaluation, Response and Safety Study of TareSphere
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07298538 on ClinicalTrials.gov ↗ ← All trials in China