Prospective Collection of Therapeutic Efficacy and Safety Data in Patients with Unresectable Hepatocellular Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Preoperative imaging examination assessed tumor load >50%;
Previous history of hepatic encephalopathy, refractory ascites, or esophageal and gastric varices rupture bleeding;
There are contraindications for TACE treatment, such as portal shunt, isolated hepatic blood flow, and obvious atherosclerosis;
Patients with extrahepatic metastasis;
Trial population
Study populations in this study are patients with primary unresectable liver cancer who have not received any previous treatment or patients with unresectable liver cancer who recurred for the first time after radical therapy and did not receive any postoperative adjuvant therapy;
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 2 trial groupsGroup A: TACE alone
Group B: TACE plus systemic therapy
Trial outcomes
Primary outcomes
1
Progression-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 monthsSecondary outcomes
1
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 months2
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 months3
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 monthsSponsors and contacts
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Source ClinicalTrials.gov