New combo therapy shows promise for tough liver cancer

NCT ID NCT05166239

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a three-drug combination for people with advanced liver cancer that has spread into the portal vein (a major blood vessel). The treatment adds a liver-directed chemotherapy infusion to two standard drugs (lenvatinib and a PD-1 inhibitor). The goal was to see if the triple therapy works better than the two-drug combo alone. The study included 66 adults with this specific type of liver cancer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

66 people

The number who actually took part.

Started

Jan 2022

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age and gender: \>18 years old and≤75 years old, both men and women. 2. All subjects must have advanced hepatocellular carcinoma with portal vein tumor thrombosis confirmed by pathological or clinical diagnosis. 3. One measurable lesion at least. 4. ECOG PS 0-1 before 1 week of treatment begnining. 5. Child-Pugh class A; ALBI class 1-2. 6. Systemic-cheomtherapy-naive and HAIC-naive. 7. BCLC C stage with PVTT (Vp1 - Vp4). 8. Without distant metastasis. 9. Patients who are expected to live more than 3 months. 10. Subjects must volunteer to participate in the study, signed informed consent, and were able to comply with the program requirements of visits and related procedures. 11. Patients with laboratory values that meet the following criteria: 1. Hemoglobin≥90 g/L; 2. Neutrophile granulocytes≥1.5×109/L; 3. Platelet count≥75×109/L; 4. Albumin≥30 g/L; 5. Total serum bilirubin ≤ 2 times upper limits of normal; 6. AST and ALT ≤ 5 times upper limits of normal; 7. Serum creatinine ≤ 1.5 times upper limits of normal; 8. Alkaline phosphatase ≤ 5 times upper limits of normal; 9. Prothrombin time or international normalized ratio ≤ 1.5 times upper limits of normal, activated partial thromboplastin time (APTT) ≤ 1.5×ULN. Exclusion Criteria: 1. Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma confirmed by histology or cytology. 2. History of malignant tumor, excluding the following cases: 3. Allergic to contrast agent. 4. Allergic to oxaliplatin. 5. History of usage of immune inhibitor drug within 14 days before the injection of PD-1 inhibitors, except nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (no more than 10 mg/day of prednisolone or other corticosteroids with equivalent physiological doses). 6. Factors influenced oral Lenvatinib, such as inability to swallow, chronic diarrhea and intestinal obstruction, or other conditions that significantly affect the administration and absorption of the drug. 7. Allergic to Lenvatinib, PD-1 inhibitors, and other mono-colonal antibodies. 8. Vaccination with live attenuated vaccine within 4 weeks before the first dose or planned during the study period. 9. Peripheral neuropathy\> Grade 1. 10. History of active autoimmune disease or autoimmune disease. 11. History of other malignant tumor, except for radically treated basal cell, squamous cell skin cancer, or cervical carcinoma in situ. 12. History of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) . 13. Clinically significant cardiovascular disease, including, but not limited to, acute myocardial infarction, severe/unstable angina or prior coronary artery bypass surgery, congestive heart failure (NYHA \>2), poorly controlled arrhythmias or arrhythmias requiring pacemaker therapy, hypertension not controlled by medication (systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg) within the past 6 months. 14. Abnormal coagulation function (INR\>1.5 or APTT\>1.5×ULN) , have bleeding tendency, or are receiving thrombolytic therapy, anticoagulation therapy or antiplatelet therapy, etc.. 15. History of inherited or acquired bleeding and thrombotic tendency, such as hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc.. 16. History of significant coughing up blood 2 months before entering the study, or the daily volume of hemoptysis reached 2.5 ml or more. 17. Patients at risk of gastrointestinal bleeding, including the following: 1. There are active peptic ulcer lesions. 2. Those who have a history of melena and hematemesis within 3 months. 3. For fecal occult blood (+) or (+/-), it is necessary to recheck the stool routine within 1 week. Those who still (+) or (+/-) must undergo gastroscopy. If there is ulcer, bleeding disease, and the treating physician believes that there is a potential risk of bleeding. 18. History of thrombosis and/or embolism within 6 months of the start of treatment. 19. Complicated infections requiring drug intervention (such as intravenous infusion of antibiotics, antifungal or antiviral drugs) within 4 weeks before the first treatment, or unexplained fever \>38.5°C during the screening period/before the first administration. 20. Participated in any other clinical research within 4 weeks before the first treatment. 21. History of psychotropic drug abuse or drug use. 22. Other serious physical, mental illnesses or laboratory abnormalities, which may increase the risk of participating in the research or interfere with the results of the research, and those who the researcher believes are not suitable for participating in this research.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Peking Univerisity Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

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Other studies related to the condition(s) this trial covers.