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Not yet recruiting NCT07156617

A Study on the Heterogeneity of Efficacy of Interventional Therapy Combined With Systemic Therapy for Liver Cancer Based on Multi-center Real-world Data

— Observational Hepatocellular Carcinoma (HCC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Interventional therapy, Systemic therapy.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma (HCC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The system assesses the heterogeneity of HCC patients in terms of therapeutic outcomes (such as rwPFS, ORR, PRO) and adverse reactions during the process of interventional therapy combined with systemic treatment. It explores the clinical characteristics and biomarker levels of patients related to heterogeneity and builds a machine learning model to predict the risk of adverse reactions, providing evidence support for the construction of a patient-centered individualized decision-making system.

Interventions

  • Procedure Interventional therapy
    Interventional therapy
  • Drug Systemic therapy
    Targeted Therapy drugs include but are not limited to Lenvatinib, Apatinib, etc. Immunotherapy drugs include but are not limited to Camrelizumab, Tislelizumab

Primary outcome measures

  • rwPFS [Time frame: up to 2 years]
Secondary outcome measures (5)
  • ORR [Time frame: up to 2 years]
  • rwOS [Time frame: up to2years]
  • rwTTP [Time frame: up to2years]
  • PRO [Time frame: up to2years]
  • AE [Time frame: up to2years]

Eligibility criteria

Inclusion criteria

  • 1\. Age ≥ 18 years old, gender not restricted; 2. Diagnosed with HCC through pathological or imaging examination, and meeting the diagnostic criteria of the "Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 Edition)"; 3. Has received or plans to receive interventional therapy combined with systemic treatment (including but not limited to DEB-TACE combined with targeted therapy, DEB-TACE combined with targeted therapy and immunotherapy, DEB-TACE combined with targeted therapy and immunotherapy other local interventional treatments (such as HAIC, ablation, particle implantation, etc.)); 4. Has completed baseline clinical information and treatment records, can cooperate with the follow-up arrangement, and has the willingness and ability to complete the entire research process; 5. Signed the informed consent form.

Exclusion criteria

  • 1\. Diagnosed with liver metastatic cancer or other primary malignant tumors that are not HCC, or with concurrent other active primary malignant tumors; 2. Clearly have severe cognitive impairment, mental illness or confusion, and are unable to cooperate with the visit or fill out the scale; 3. Expected survival period is less than 3 months or clinical judgment indicates that follow-up cannot be completed; 4. Liver function is in decompensation, with Child-Pugh classification as C; 5. The investigator considers any other situation that is not suitable for participating in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 14 centers
  • The Second Affiliated Hospital of Hainan Medical Universsity — Haikou
  • Xingtai No.5 Hospital — Xingtai
  • Deng zhou People's Hospital — Dengzhou
  • The Second People's Hospital of Jiaozuo — Jiaozuo
  • Huai He Hospital of Henan University — Kaifeng
  • Luo Yang Central Hospital — Luoyang
  • The First Affiliated Hospital of Henan University of science and Technology — Luoyang
  • First People's Hospital of Shangqiu — Shangqiu
  • … and 6 more centers

Identifiers

NCT: NCT07156617 · 2025-KY-1142-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗