About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Hepatocellular carcinoma
Trial design
Cohort
Prospective
Treatments tested in this trial
Interventional therapy
Procedure/SurgeryInterventional therapy
Systemic therapy
DrugTargeted Therapy drugs include but are not limited to Lenvatinib, Apatinib, etc. Immunotherapy drugs include but are not limited to Camrelizumab, Tislelizumab
Treatment groups
Trial outcomes
Primary outcomes
rwPFS
The definition of rwPFS is the time from the first administration of combined therapy to the first imaging assessment indicating tumor progression or death, whichever occurs first.
Secondary outcomes
ORR
ORR is defined as the proportion of patients who achieve complete remission (CR, Complete Response) and partial remission (PR, Partial Response) according to the mRECIST criteria.
rwOS
The rwOS is defined as the time from the first administration of combined therapy to the occurrence of any cause of death. If there is no death record for the patient, the last visit time will be used as the censored value.
rwTTP
The rwTTP is defined as the time from the first administration of combined therapy to the first imaging assessment revealing tumor progression.
PRO
The PRO score includes the scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and its liver cancer module (EORTC QLQ-HCC18) that were filled out by the patients themselves.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Xuhua Duan
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: