Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Conversion Therapy With FOLFOX-HAIC Plus Lenvatinib And Tislelizumab For Hepatocellular Carcinoma With Vp3 Portal Vein Tumor Thrombus

Conversion Therapy With FOLFOX-HAIC Plus Lenvatinib and Tislelizumab for Hepatocellular Carcinoma With Vp3 Portal Vein Tumor Thrombus: A Prospective, Multicenter, Single-arm Study

Conversion Therapy With FOLFOX-HAIC Plus Lenvatinib And Tislelizumab For Hepatocellular Carcinoma With Vp3 Portal Vein Tumor Thrombus (NCT07483359) is a Phase 2 interventional studying Hepatocellular Carcinoma (HCC) and Portal Vein Tumor Thrombus, sponsored by First Hospital of China Medical University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Hepatocellular Carcinoma (HCC) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 38 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: Participants must meet all of the following inclusion criteria to be enrolled in this trial: 1. Voluntarily sign the written willing to sign a consent form form. 2. Age 18 to 80 years (inclusive), male or female. 3. diagnosed by tissue sample (biopsy-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. 4. No prior systemic anti-tumor therapy (including targeted therapy, immunotherapy, and systemic chemotherapy). 5. 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). 6. At least one measurable target lesion according to RECIST v1.1 criteria. 7. Expected survival time of ≥ 3 months. 8. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1. 9. Child-Pugh liver function class A or B (score ≤ 7). 10. Adequate major organ function, meeting the following baseline laboratory criteria: - Hematology: blood count (hemoglobin) at least 90 g/L; Absolute Neutrophil Count (ANC) ≥ 1.5 x 10\^9/L; Platelet count ≥ 75 x 10\^9/L. - Biochemistry: Albumin ≥ 28 g/L; Total Bilirubin ≤ 3 x Upper Limit of Normal (ULN); AST and ALT ≤ 5 x ULN; Alkaline Phosphatase (ALP) ≤ 5 x ULN; Serum Creatinine ≤ 1.5 x ULN. - Coagulation: INR or Prothrombin Time (PT) ≤ 1.5 x ULN; Activated Partial Thromboplastin Time (APTT) ≤ 1.5 x ULN. 11. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to enrollment, must not be breastfeeding, and must agree to use highly effective contraception during the study treatment and for at least 6 months after the last dose. 12. Good compliance and willingness to cooperate with all study-related follow-up procedures. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: Participants must meet all of the following inclusion criteria to be enrolled in this trial: 1. Voluntarily sign the written informed consent form. 2. Age 18 to 80 years (inclusive), male or female. 3. 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. 4. No prior systemic anti-tumor therapy (including targeted therapy, immunotherapy, and systemic chemotherapy). 5. 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). 6. At least one measurable target lesion according to RECIST v1.1 criteria. 7. Expected survival time of ≥ 3 months. 8. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1. 9. Child-Pugh liver function class A or B (score ≤ 7). 10. Adequate major organ function, meeting the following baseline laboratory criteria: * Hematology: Hemoglobin ≥ 90 g/L; Absolute Neutrophil Count (ANC) ≥ 1.5 x 10\^9/L; Platelet count ≥ 75 x 10\^9/L. * Biochemistry: Albumin ≥ 28 g/L; Total Bilirubin ≤ 3 x Upper Limit of Normal (ULN); AST and ALT ≤ 5 x ULN; Alkaline Phosphatase (ALP) ≤ 5 x ULN; Serum Creatinine ≤ 1.5 x ULN. * Coagulation: INR or Prothrombin Time (PT) ≤ 1.5 x ULN; Activated Partial Thromboplastin Time (APTT) ≤ 1.5 x ULN. 11. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to enrollment, must not be breastfeeding, and must agree to use highly effective contraception during the study treatment and for at least 6 months after the last dose. 12. Good compliance and willingness to cooperate with all study-related follow-up procedures. 13. Assessed by the MDT as "Potentially Resectable" according to the "Chinese expert consensus on conversion and perioperative therapy of primary liver cancer (2024 edition)". This is defined as participants who are temporarily unsuitable for upfront surgical resection due to oncological factors (e.g., Vp3 PVTT indicating a high risk of early post-operative recurrence) or technical factors (e.g., massive tumor size leading to insufficient future liver remnant \[FLR\]), but who are expected to convert to an R0 resection and achieve significant clinical benefit following downstaging with the combination of FOLFOX-HAIC and systemic therapy. Exclusion Criteria: Participants who meet any of the following criteria will be excluded from the study: 1. History of other active malignancies within 5 years (except for adequately treated basal cell carcinoma of the skin or papillary thyroid cancer). 2. Evidence of extrahepatic metastasis confirmed by chest, abdomen, and pelvis CT and/or MRI scans. 3. Presence of clinically significant ascites. 4. History of hepatic encephalopathy. 5. 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. 6. Severe infection within 4 weeks prior to enrollment, including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia. 7. 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). 8. 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. 9. Severe vascular disease within 6 months (e.g., aortic aneurysm requiring surgical repair or peripheral arterial thrombosis); or a current or recent history of active autoimmune disease or immunodeficiency (including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis). 10. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of the investigational drugs, may affect the interpretation of the results, or may place the patient at high risk for treatment-related complications. 11. Use of systemic immunosuppressive medications within 2 weeks prior to the first dose of study treatment, or the expected need for long-term systemic immunosuppressive therapy during the study. Exceptions permitting the use of corticosteroids include: (1) prophylactic use to prevent allergic reactions to imaging contrast media (e.g., short-term dexamethasone); (2) topical, ophthalmic, intra-articular, otic, or inhaled corticosteroids with minimal systemic absorption; (3) physiological replacement doses of systemic corticosteroids (defined as ≤ 10 mg/day of prednisone or an equivalent corticosteroid). 12. Evidence of bleeding diathesis or severe coagulopathy. 13. Patients preparing to undergo, or who have previously received, a solid organ or allogeneic bone marrow transplant.

Treatments Being Tested

COMBINATION_PRODUCT

HAIC + Tislelizumab +lenvatinib

Tislelizumab: 200 mg administered intravenously each 21-day cycle. FOLFOX-HAIC: Administered every 21 days for up to a maximum of 6 cycles. The regimen consists of Oxaliplatin 85 mg/m², Leucovorin 400 mg/m², and 5-Fluorouracil 2500 mg/m² given as a continuous hepatic arterial infusion over 46-48 hours. Lenvatinib: Administered orally once daily on a continuous basis. Dosing is weight-adjusted: 12 mg/day for patients weighing ≥60 kg, and 8 mg/day for patients weighing \<60 kg.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The First Hospital of China Medical University
Shenyang, Liaoning, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07483359), the sponsor (First Hospital of China Medical University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07483359 clinical trial studying?

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-… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07483359?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07483359?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07483359. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07483359. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.