Conversion Therapy With FOLFOX-HAIC Plus Lenvatinib And Tislelizumab For Hepatocellular Carcinoma… (NCT07483359) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Conversion Therapy With FOLFOX-HAIC Plus Lenvatinib And Tislelizumab For Hepatocellular Carcinoma With Vp3 Portal Vein Tumor Thrombus
China38 participantsStarted 2026-03
Plain-language summary
Patients with hepatocellular carcinoma (HCC) complicated by Vp3 portal vein tumor thrombus (PVTT) face a poor prognosis and are typically ineligible for surgical resection. This prospective study evaluates a conversion therapy regimen-utilizing a combination of FOLFOX-HAIC, Lenvatinib, and Tislelizumab-designed to induce significant regression of both the tumor burden and the PVTT. The primary objective is to determine the Technical Resectability Rate (TRR), assessing the potential for this triple-combination therapy to downstage initially unresectable disease to a state suitable for curative-intent R0 surgical resection.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Voluntarily sign the written informed consent form.
✓. Age 18 to 80 years (inclusive), male or female.
✓. Histologically or cytologically confirmed Hepatocellular Carcinoma (HCC) according to the "Clinical Practice Guideline for Primary Liver Cancer (2024 Edition)," and evaluated by a Multi-Disciplinary Team (MDT) as initially unresectable.
✓. No prior systemic anti-tumor therapy (including targeted therapy, immunotherapy, and systemic chemotherapy).
✓. Barcelona Clinic Liver Cancer (BCLC) stage C and China Liver Cancer (CNLC) stage IIIa, complicated with imaging-confirmed Vp3 portal vein tumor thrombus (PVTT, defined as tumor thrombus invading the first-order branches of the portal vein but not the main trunk).
✓. At least one measurable target lesion according to RECIST v1.1 criteria.
✓. Expected survival time of ≥ 3 months.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
✕. History of other active malignancies within 5 years (except for adequately treated basal cell carcinoma of the skin or papillary thyroid cancer).
✕. Evidence of extrahepatic metastasis confirmed by chest, abdomen, and pelvis CT and/or MRI scans.
✕. Presence of clinically significant ascites.
✕. History of hepatic encephalopathy.
✕. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on chest CT scan at screening.
✕. Severe infection within 4 weeks prior to enrollment, including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia.
✕. History of hypertensive crisis; or major cardiovascular disease within 3 months prior to starting study treatment (e.g., New York Heart Association \[NYHA\] Class II or worse heart failure, myocardial infarction, cerebrovascular accident, unstable arrhythmia, or unstable angina).
✕. Inadequately controlled arterial hypertension, defined as systolic blood pressure (BP) ≥ 150 mmHg and/or diastolic BP \> 100 mmHg (based on an average of ≥ 3 BP readings obtained from ≥ 2 measurements). Achieving these parameters through the use of antihypertensive therapy is permitted.