Hepatocellular carcinoma
Conditions
Interventions
Observation group:None
Sponsors
Mengchao Hepatobiliary Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years and <=75 years, any gender. 2. Confirmed diagnosis of Hepatocellular Carcinoma (HCC) based on the Chinese guidelines for the diagnosis and treatment of hepatocellular carcinoma or internationally accepted guidelines, verified by pathology or meeting the imaging diagnostic criteria for HCC. 3. Clinically determined to have advanced, unresectable, or unsuitable for curative treatment HCC, and scheduled to receive targeted therapy combined with immunotherapy. 4. At least one evaluable lesion available before enrollment, suitable for ultrasound image acquisition and subsequent efficacy evaluation. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0–1. 6. Child-Pugh class A or B. 7. Major organ functions deemed acceptable for systemic therapy and routine follow-up as assessed by the clinician. 8. The patient or their legal representative is able to understand the study content and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received immune checkpoint inhibitor combined with targeted therapy, where the baseline starting point of this study cannot be clearly determined. 2. Patients with other active malignancies that may affect efficacy assessment or survival outcomes. 3. Patients with severe cardiac, pulmonary, renal, or neurological diseases, assessed by the investigator as unsuitable for enrollment or unable to complete follow-up. 4. Patients with Child-Pugh class C, or uncontrolled severe liver failure. 5. Patients with active severe infections, active gastrointestinal bleeding, or other acute critical conditions requiring priority management. 6. Pregnant or lactating women. 7. Patients with mental, cognitive, or communication disorders who are unable to comply with study procedures or provide valid informed consent. 8. Other conditions considered by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Status at 12 Weeks After Treatment Initiation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Disease Control Rate (DCR);Progression-Free Survival (PFS);Overall Survival (OS);Multimodal Ultrasound Quantitative and Semi-Quantitative Parameters;Ultrasomics Features;Serological and Laboratory Parameters;Model Performance Metrics;Treatment-Related Adverse Events (TRAEs); | — |
Countries
China
Contacts
Public ContactHaibin Tu
Mengchao Hepatobiliary Hospital of Fujian Medical University
Outcome results
None listed