Drug cocktail before surgery may cut liver cancer recurrence
NCT ID NCT07518706
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase II trial tests whether giving two drugs (tislelizumab and lenvatinib) before surgery can reduce the risk of liver cancer returning in patients with early-stage disease and narrow surgical margins. Sixty participants will be randomly assigned to receive the drug combination followed by surgery, or surgery alone. The main goal is to see if the combo improves one-year recurrence-free survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tislelizumab (immunotherapy) and lenvatinib (targeted therapy)
- What this could lead to
- If successful, this combination before surgery could lower the chance of liver cancer coming back after surgery, improving long-term survival.
- What could go wrong
- This is a small, early-phase study (60 people) and results may not apply to all patients. The drugs can cause side effects like fatigue, high blood pressure, or immune reactions.
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
-
About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Apr 2026
An estimate. Start dates often move.
- Expected to finish
-
Apr 2029
An estimate. End dates often move.
- 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 years and older
- 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 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. The patient voluntarily participates in this study and provides written informed consent. 2. Age ≥18 years at the time of consent; male or female. 3. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1. 4. Child-Pugh class A hepatic function. 5. Histologically/cytologically confirmed, or clinically diagnosed according to accepted diagnostic criteria, primary hepatocellular carcinoma (HCC), with a single tumor measuring 2-5 cm in greatest diameter (CNLC stage IA). 6. At enrollment, the lesion meets the criteria for surgically resectable disease per the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 edition); and an anticipated narrow surgical margin (resection margin \<1 cm) is expected due to tumor size and/or location, including any of the following: * Lesion adjacent to the main trunk of the portal vein or first-order branches; * Lesion adjacent to the inferior vena cava or the root of the hepatic veins; * Lesion located in the caudate lobe. 7. No prior local or systemic antitumor therapy for HCC. 8. At least one measurable lesion per RECIST v1.1. 9. Adequate function of major organs within 14 days prior to initiation of study treatment, as defined below: (1) Hematology (no blood transfusion within 14 days before screening; no granulocyte colony-stimulating factor \[G-CSF\] use; and no pharmacologic correction except for hemoglobin): absolute neutrophil count (ANC) ≥1.5×10\^9/L; platelets ≥75×10\^9/L; hemoglobin ≥90 g/L. (2) Serum chemistry (no albumin infusion within 14 days before screening): serum albumin ≥29 g/L; total bilirubin ≤1.5× upper limit of normal (ULN); alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤5×ULN; serum creatinine ≤1.5×ULN or creatinine clearance (CrCl) \>50 mL/min (Cockcroft-Gault formula below). Male: CrCl = (140 - age) × weight / (72 × serum Cr) Female: CrCl = \[(140 - age) × weight / (72 × serum Cr)\] × 0.85 Weight in kg; serum Cr in mg/dL. (3) International normalized ratio (INR) ≤2.3, or prothrombin time (PT) prolongation ≤6 seconds above the institutional normal control. (4) Urine protein \<2+; if urine protein is ≥2+, a 24-hour urine protein quantification may be performed, and patients with 24-hour urine protein \<1.0 g are eligible. 10\. Viral hepatitis management: * For patients with active hepatitis B virus (HBV) infection: HBV DNA must be \<500 IU/mL (if the site reports in copies/mL only, \<2,500 copies/mL), and the patient must have received anti-HBV therapy for at least 14 days before initiation of study treatment (per local standard of care, e.g., entecavir) and be willing to continue antiviral therapy throughout the study. * Patients who are hepatitis C virus (HCV) RNA positive must receive antiviral therapy per local standard treatment guidelines, and liver function abnormalities must be no greater than CTCAE Grade 1. 11\. Contraception: Women of childbearing potential must agree to use effective contraception (e.g., intrauterine device, oral contraceptives, or condoms) during study treatment and for 6 months after the last dose; a negative serum or urine pregnancy test within 7 days prior to enrollment is required; women must not be breastfeeding. Male participants must agree to use effective contraception during the study and for 6 months after the end of the study. 12\. The participant is able and willing to comply with the protocol requirements and follow-up schedule. Exclusion Criteria: 1. Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed-cell carcinoma, or fibrolamellar carcinoma; any other active malignancy concurrent with HCC or within the past 5 years, except for definitively treated localized tumors (e.g., basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, or breast carcinoma in situ). 2. Planned or prior solid-organ transplantation or allogeneic bone marrow transplantation (corneal transplantation is allowed). 3. Known hypersensitivity to macromolecular protein products, or known allergy to any excipients of tislelizumab. 4. Any active autoimmune disease or a history of autoimmune disease. 5. Use of immunosuppressive agents, or systemic or absorbable topical corticosteroid therapy for immunosuppressive purposes (dose \>10 mg/day prednisone or equivalent), that is ongoing within 2 weeks prior to enrollment. 6. Clinically symptomatic ascites or pleural effusion requiring therapeutic paracentesis, thoracentesis, or drainage. 7. Uncontrolled clinically significant cardiac symptoms or disease, including: (1) New York Heart Association (NYHA) class II or higher heart failure; (2) Unstable angina; (3) Myocardial infarction within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention. 8\. Current (within the past 3 months) gastrointestinal conditions including esophageal varices, active gastric or duodenal ulcer, ulcerative colitis, portal hypertension, or active bleeding from unresected tumor(s), or any other condition judged by the investigator to pose a risk of gastrointestinal bleeding or perforation. 9\. History or current evidence of severe bleeding (blood loss \>30 mL within the past 3 months), hemoptysis (\>5 mL of fresh blood within the past 4 weeks), or a thromboembolic event within the past 12 months (including stroke and/or transient ischemic attack). 10\. Active infection, or fever of unknown origin \>38.5°C during screening or prior to the first dose (fever judged by the investigator to be tumor-related is allowed). 11\. Congenital or acquired immunodeficiency, such as HIV infection. 12. Receipt of a live attenuated vaccine within 4 weeks prior to administration of study treatment. 13\. Use of traditional Chinese medicine with antitumor indications within 2 weeks prior to the first dose, or receipt of medications with immunomodulatory effects within 2 weeks prior to the first dose. 14\. Known history of abuse of psychoactive drugs, alcoholism, or illicit drug use. 15\. Ongoing treatment-related serious adverse events prior to enrollment in this study. 16\. Any condition that, in the investigator's opinion, makes the participant unsuitable for the study, including factors that may necessitate premature discontinuation (e.g., other serious diseases \[including psychiatric disorders\] requiring concomitant treatment, severe laboratory abnormalities, or family/social circumstances that may compromise participant safety or interfere with data and specimen collection).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for HCC - hepatocellular carcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a website help liver cancer patients care for themselves during chemoembolization?
- Can removing the spleen help the liver fight cancer?
- Liver cancer treatments under Real-World scrutiny
- Can protein patterns in stored tumors point to new treatment targets?
- A smarter way to choose liver cancer treatment? a new model aims to match therapy to the patient.
- Can a Three-Pronged attack shrink liver tumors before surgery?