The malignant degree of middle and advanced liver cancer is very high, and the survival prognosis of patients is very poor. TACE is currently the standard treatment for unresectable liver cancer recommended by several international authoritative guidelines. However, TACE can only extend survival from 8 months to 13 months, and the prognosis for patients with unresectable liver cancer is still not optimistic. In recent years, some studies have suggested that the combination of TACE and systemic therapy can prolong OS and PFS, but a number of prospective studies have found that the combination of TACE and targeted therapy can not improve the prognosis of unresectable liver cancer. However, TACE as a non-radical treatment is difficult to achieve complete tumor necrosis, so it is still unknown which treatment combination can best improve the prognosis. This trial is an observational clinical trial to explore the efficacy and safety of TACE combined targeting/immunotherapy for unresectable hepatocellular carcinoma. Clinical data of patients with unresectable liver cancer treated in our hospital from March 2023 to March 2025 are intended to be collected to evaluate the efficacy and safety of TACE combined with different systems for unresectable liver cancer.
Study Type
OBSERVATIONAL
Enrollment
500
The First Affiiated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGProgression-free survival
Defined as the time from commencement of enrollment to progression of disease or death throughout the trial. Patients who withdraw or are lost to follow-ups will be treated as censored data, and the last date of known living without progression will be used as the last survival time. Patients whose diseases have not progressed at ending of this study will be treated as censored data, and the last date of known living without progression will be used as the last survival time.
Time frame: 24 months
Overall survival
Defined as the time from the commencement of enrollment to all-cause death throughout the trial. Patients who withdraw or are lost to follow-ups will be treated as censored data, and the last date of known living will be used as the last survival time. Patients who still survive at ending of this study will also be treated as censored data, and the last date of known living is used as the last survival time.
Time frame: 24 months
tumor response
tumor response is evaluated based on mRECIST and RECIST v1.1 criteria, including complete response, partial response, stable disease, and progression disease.
Time frame: 24 months
Safety
Defined as one of ≥ grade 3 hematologic or non-hematologic toxicity events. The severity of adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Time frame: 24 months
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