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NCT Number: NCT07298538

Long-Term Survival With Lenvatinib-Based Therapy in Unresectable Liver Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 3-year Overall Survival Rate Estimated by Kaplan-Meier Method

    Time frame: 3 years after treatment initiation

    3-year cumulative survival rate estimated based on the Kaplan-Meier method

Secondary outcomes

  1. Overall survival (OS)

    Time frame: Up to 5 years after treatment initiation

    The time interval from treatment initiation to the date of death due to any cause

  2. Event-free survival (EFS)

    Time frame: Up to 5 years after treatment initiation

    The time interval from treatment initiation to the occurrence of any event, including disease progression, recurrence (surgical patients), discontinuation of treatment for any reason, or death. EFS is assessed by RECIST v1.1.

  3. 4-year and 5-year OS rates

    Time frame: 4 years and 5 years after treatment initiation

    4-year and 5-year cumulative survival rates estimated based on the Kaplan-Meier method

  4. Objective response rate (ORR)

    Time frame: Up to 12 months after treatment initiation

    The proportion of patients who achieved the best overall response (BOR) of complete response (CR) or partial response (PR) as assessed by the investigator per RECIST v1.1

  5. Incidence of Adverse Events (AEs) and Surgical Complications

    Time frame: AEs: from treatment initiation through 30 days after last dose of lenvatinib-based therapy; Surgical complications: perioperative period (day of surgery through 30 days post-surgery)

    Adverse Events and surgical complications

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Official study title

Long-term Survival of Unresectable Hepatocellular Carcinoma Patients Receiving Lenvatinib-based Therapy: A Retrospective, Multicenter Propensity Score Matching Study

Important dates

Study start
2019
Primary completion
2025
Study completion
2027
First posted
Dec 23, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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