Conversion Therapy With FOLFOX-HAIC Plus Lenvatinib And Tislelizumab For Hepatocellular Carcinoma… (NCT07483359) | Clinical Trial Compass
RecruitingPhase 2
Conversion Therapy With FOLFOX-HAIC Plus Lenvatinib And Tislelizumab For Hepatocellular Carcinoma With Vp3 Portal Vein Tumor Thrombus
China38 participantsStarted 2026-05-20
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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
Exclusion criteria
. 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.