New combo therapy shows promise for tough liver cancer
NCT ID NCT05166239
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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66 people
The number who actually took part.
- Started
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Jan 2022
- Finished
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Dec 2025
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Peking Univerisity Cancer Hospital
Beijing, Beijing Municipality, 100142, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could a daily mineral make liver cancer therapy work better?
- Can a triple drug attack stop liver cancer from coming back?
- Can a custom vaccine train the body to fight liver cancer?
- Personalized liver cancer treatment: a quest for predictive biomarkers