NCT07340502Not yet recruiting
TACE Versus HAIC, Combined With PD-1 Inhibitors and Lenvatinib for Unresectable Hepatocellular Carcinoma
TACE Versus HAIC, Combined With PD-1 Inhibitors and Lenvatinib for Unresectable Hepatocellular Carcinoma: a Multicenter, Prospective, Observational Cohort Study
Source: ClinicalTrials.gov · Last updated 14 Jan 2026
Brief summary (registry, in English)
Although the combination of transarterial chemoembolization (TACE) with PD-1 inhibitor plus lenvatinib has become a new standard, the therapeutic efficacy for unresectable hepatocellular carcinoma (uHCC) still requires improvement, as TACE remains limited for patients with multifocal lesions, hypovascular tumors, or those complicated with portal vein tumor thrombosis (PVTT). Hepatic arterial infusion chemotherapy (HAIC), as an alternative locoregional therapy, has demonstrated advantages in treating these refractory cases. Therefore, this study innovatively designs a prospective cohort study to conduct a comparison of the two triple-combination regimens-"HAIC plus PD-1 inhibitor and lenvatinib" versus "TACE plus PD-1 inhibitor and lenvatinib"-in terms of real-world efficacy and safety, with a focus on enrolling patients who are likely to have suboptimal responses to TACE. This research aims to provide high-level evidence for selecting the optimal combined locoregional strategy for uHCC patients, thereby directly guiding clinical practice and potentially advancing the optimization of treatment strategies and personalized precision medicine to improve patient survival outcomes.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 364 (estimated)
- First submitted
- 6 Jan 2026
- Start date
- Jan 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Tongji Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07340502
What you commit to
- Study type: Observational
- Planned participants: 364
- From Jan 2026 to the primary completion date, Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent other malignancies or recurrent hepatocellular carcinoma;
Other illness
- Any active, known, or suspected autoimmune disease;
- History of hypersensitivity to any component of PD-1 inhibitors or lenvatinib;
- Human immunodeficiency virus (HIV) infection; or active viral hepatitis (e.g., hepatitis B or C);
Other
- Decompensated liver cirrhosis;
- Tumor thrombus involving the inferior vena cava, hepatic veins, or the main portal vein trunk.
Who the study is looking for
- Aged between 18 and 75 years;
- Tumor stage classified as BCLC-A to -C, with no evidence of extrahepatic metastasis;
- Newly diagnosed, treatment-naïve hepatocellular carcinoma with no prior anticancer therapy;
- Child-Pugh liver function score ≤ 7;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1;
- Absence of severe organic diseases affecting major organs (e.g., heart, lung, brain).
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.