A Phase 2 interventional study of HAIC + Tislelizumab +lenvatinib in Hepatocellular Carcinoma (HCC) and Portal Vein Tumor Thrombus, sponsored by First Hospital of China Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by First Hospital of China Medical University · Phase 2, Interventional, and Treatment
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.
This prospective, multicenter, single-arm clinical trial evaluates the efficacy and safety of a triple-combination conversion therapy for patients with initially unresectable hepatocellular carcinoma (HCC) complicated by Vp3 portal vein tumor thrombus (PVTT). The study aims to enroll 38 participants to assess the technical resectability rate (TRR) as the primary endpoint. Participants undergo a 21-day treatment cycle consisting regimens of intravenous Tislelizumab, FOLFOX-based hepatic arterial infusion chemotherapy (HAIC), while receiving daily oral Lenvatinib. This combination is designed to leverage the synergistic effects of high-concentration local chemotherapy and systemic targeted-immunotherapy to induce significant regression of both the tumor burden and the PVTT.
The clinical pathway centers on regular response evaluations conducted every two cycles using multimodal radiological imaging. During these intervals, a dual-evaluation mechanism is employed: a Multi-Disciplinary Team (MDT) reviews the clinical and radiological data to guide real-time surgical decision-making, while a Blinded Independent Review Committee (IRC) independently evaluates the scans to formally determine the primary endpoint of technical resectability. This assessment focuses on anatomical feasibility for R0 resection, the adequacy of the future liver remnant, and the successful downstaging of the PVTT. Patients meeting the clinical conversion criteria proceed to curative-intent surgical intervention, followed by a pathological complete response (pCR) assessment.
For participants who remain technically unresectable but continue to demonstrate clinical benefit, the HAIC intervention is limited to a maximum of six cycles. In these cases, systemic targeted and immunotherapy are maintained until disease progression, intolerable toxicity, or a maximum treatment duration of 24 months. The study officially concludes upon the earliest occurrence of either: the completion of the protocol-defined one-year overall survival follow-up for the final enrolled participant (including the achievement of the pre-specified data cutoff), or the point at which all surviving participants have experienced definitive disease progression or death and further data collection is no longer required.
3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.
This study's planned enrollment of 38 is below the median of 54 across 2,618 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →First Hospital of China Medical University is the lead sponsor of 62 studies on the registry; 34 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet all of the following inclusion criteria to be enrolled in this trial:
Adequate major organ function, meeting the following baseline laboratory criteria:
Exclusion Criteria:
Participants who meet any of the following criteria will be excluded from the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive a 21-day cycle consisting of intravenous immunotherapy (Tislelizumab), local hepatic arterial infusion chemotherapy (FOLFOX-HAIC), and daily oral targeted therapy (Lenvatinib).
Combination Product: HAIC + Tislelizumab +lenvatinib
Drug pages: 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.
Technical Resectability Rate (TRR)
The percentage of participants whose disease converts from initially unresectable to technically resectable, as evaluated by a Blinded Independent Review Committee (IRC) based on multimodal radiological imaging. The criteria for successful conversion include the anatomical feasibility of achieving an R0 resection, the adequacy of the future liver remnant (FLR), and the successful downstaging of the Vp3 portal vein tumor thrombus (PVTT).
Time frame: Up to approximately 2 years.
1-Year Overall Survival (OS) Rate
The percentage of participants who remain alive at 12 months from the date of the first dose of study treatment.
Time frame: 12 months from the first dose of study treatment.
Progression-Free Survival (PFS) per RECIST v1.1
Time from the first dose of study treatment to the first documented objective disease progression, as assessed by the IRC using RECIST v1.1 criteria, or death from any cause, whichever occurs first.
Time frame: Up to approximately 2 years.
Progression-Free Survival (PFS) per mRECIST
Time from the first dose of study treatment to the first documented objective disease progression, as assessed by the IRC using modified RECIST (mRECIST) criteria for hepatocellular carcinoma, or death from any cause, whichever occurs first.
Time frame: Up to approximately 2 years.
Time to Progression (TTP) per RECIST v1.1
Time from the first dose of study treatment to the first documented objective disease progression, as assessed by the IRC using RECIST v1.1 criteria.
Time frame: Up to approximately 2 years.
Time to Progression (TTP) per mRECIST
Time from the first dose of study treatment to the first documented objective disease progression, as assessed by the IRC using modified RECIST (mRECIST) criteria for hepatocellular carcinoma.
Time frame: Up to approximately 2 years.
Objective Response Rate (ORR) per RECIST v1.1
The percentage of participants who achieve a confirmed Complete Response (CR) or Partial Response (PR), as assessed by the Blinded Independent Review Committee (IRC) using RECIST v1.1 criteria. To be considered a confirmed response, the CR or PR must be maintained and verified by a subsequent radiological assessment conducted at least 4 weeks (28 days) after the initial response criteria are met.
Time frame: Up to approximately 2 years.
Objective Response Rate (ORR) per mRECIST
The percentage of participants who achieve a confirmed Complete Response (CR) or Partial Response (PR), as assessed by the Blinded Independent Review Committee (IRC) using modified RECIST (mRECIST) criteria, which specifically evaluates viable (arterially enhancing) tumor tissue. To be considered a confirmed response, the CR or PR must be maintained and verified by a subsequent radiological assessment conducted at least 4 weeks (28 days) after the initial response criteria are met.
Time frame: Up to approximately 2 years.
Portal Vein Tumor Thrombus (PVTT) Response Rate
The percentage of participants in the Intent-to-Treat (ITT) population who achieve an objective response in the portal vein tumor thrombus. This is defined as either a PVTT Complete Response (PVTT-CR; complete disappearance of the thrombus with vascular recanalization) or a PVTT Partial Response (PVTT-PR; a downgrade in the Vp classification, such as from Vp3 to Vp2 or Vp1), as evaluated by the IRC using multimodal radiological imaging.
Time frame: Up to approximately 2 years.
Actual Resection Rate (ARR)
The percentage of participants in the Intent-to-Treat (ITT) population who actually undergo and successfully complete a curative-intent R0 surgical resection following the study treatment.
Time frame: Up to approximately 2 years.
Pathological Complete Response (pCR) Rate
The percentage of participants undergoing surgical resection who achieve a pathological complete response (pCR). This is defined as the complete absence of any residual viable tumor cells in both the primary hepatic lesion and the resected portal vein tumor thrombus (PVTT), as confirmed by post-operative histopathological examination of the resected specimens.
Time frame: Up to approximately 2 years.
Incidence and Severity of Adverse Events (AEs)
The number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded. The severity of all AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Special attention will be given to tracking adverse events of special interest (AESIs), including HAIC-related complications and immune-related adverse events (irAEs).
Time frame: Through 30 days after the last dose of study treatment (up to 2 years).
Plan to share: No
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Studies of the drugs tested here: Tislelizumab · Lenvatinib
First Hospital of China Medical University