NCT06904183RecruitingPhase 2
Lenvatinib, Sintilimab, and DEB-TACE With/Without HAIC for HCC >7 cm With PVTT
Lenvatinib, Sintilimab, and Drug-Eluting Beads Transarterial Chemoembolization With or Without Hepatic Arterial Infusion Chemotherapy for Hepatocellular Carcinoma >7 cm With Portal Vein Tumor Thrombus: A Multicenter, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
This study is conducted to evaluate the efficacy and safety of lenvatinib plus sintilimab, transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (LEN+SIN+DEB-TACE+HAIC) versus lenvatinib plus sintilimab and DEB-TACE (LEN+SIN+DEB-TACE) for large hepatocellular carcinoma (\> 7cm) with portal vein tumor thrombosis (PVTT).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- First submitted
- 25 Mar 2025
- Start date
- 1 Apr 2025
- Primary completion date
- 31 Mar 2029
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06904183
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 320
- From 1 Apr 2025 to the primary completion date, 31 Mar 2029
- 1 site in 1 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
- previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy
Other illness
- organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment
- history of other malignancies
- uncontrollable infection
- history of HIV
- history of organ or cells transplantation
Other
- accompanied with vena cava tumor thrombus
- central nervous system involvement
Who the study is looking for
- a confirmed diagnosis of HCC
- the largest intrahepatic lesion \>7 cm
- presence of PVTT on imaging
- tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment
- Eastern Cooperative Oncology Group performance status ≤1
- Child-Pugh class A/B
- adequate hematologic and organ function, with leukocyte count\>3.0×10\^9/L, neutrophil count\>1.5×10\^9/L, platelet count≥75×10\^9/L, hemoglobin 85 g/L, alanine transaminase and aspartate transaminase≤5×upper limit of the normal, creatinine clearance rate≤1.5×upper limit of the normal; prothrombin time prolongation ≤4 seconds
- life expectancy of at least 3 months
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The second Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.