New immunotherapy combo aims to stop liver cancer return after surgery
NCT ID NCT07658105
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase II trial tests whether eparlitozoviril, a drug that blocks two immune checkpoints (PD-1 and CTLA-4), can prevent liver cancer from coming back after surgery in patients with microvascular invasion (MVI), a high-risk feature. About 60 participants will receive the drug for up to 6 months or be monitored closely. The main goal is to see how many remain cancer-free after one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- eparlitozoviril (a dual immunotherapy drug targeting PD-1 and CTLA-4)
- What this could lead to
- If successful, this could point toward a new standard treatment to lower the chance of liver cancer returning after surgery in high-risk patients.
- What could go wrong
- This is a small, early-phase study (60 people) at a single center, so results may not apply broadly. Immunotherapy can cause serious side effects, and the drug may not improve outcomes compared to active surveillance.
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
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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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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- 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 75 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: * Voluntarily enroll in the trial and provide signed written informed consent. * Aged between 18 and 75 years (inclusive), male or female. * Underwent curative resection for hepatocellular carcinoma 4 to 6 weeks prior to enrollment. * Pathologically confirmed hepatocellular carcinoma (HCC) with microvascular invasion (MVI). * No evidence of recurrence or metastasis confirmed by imaging examinations at least 4 weeks after surgery. * Liver function classified as Child-Pugh Class A (score: 5-6 points). * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1. * For females of childbearing potential (non-menopausal or not surgically sterilized): serum pregnancy test must be negative within 7 days before administration of study drug. * All female and male participants of childbearing potential must use effective contraception during study drug treatment and for 60 days after the last dose. * Adequate function of major organs, meeting the following criteria (no blood transfusion or G-CSF administered within 14 days before screening; no albumin used within 14 days before screening): Hematology: 1. Hemoglobin ≥ 90 g/L 2. Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L 3. Platelet count ≥ 75×10⁹/L Serum biochemistry: 4. Albumin ≥ 28 g/L 5. Total bilirubin ≤ 1.5 × upper limit of normal (ULN) 6. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 × ULN 7. Creatinine ≤ 1.5 × ULN Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN Exclusion Criteria: * Pathologically confirmed mixed hepatocellular carcinoma and intrahepatic cholangiocarcinoma (HCC-ICC). * Positive surgical margin or tumor rupture. * History of other malignancies within the past 5 years, except for patients who have received curative treatment with no evidence of disease for 5 consecutive years. This 5-year exclusion rule does not apply to patients with completely resected basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ or other carcinoma in situ. * History of congenital or acquired immunodeficiency disorders, either current or prior. * Active or documented history of autoimmune or inflammatory diseases (including but not limited to autoimmune hepatitis, interstitial lung disease, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, hypophysitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilator therapy). Patients with vitiligo or childhood asthma fully resolved without any intervention in adulthood are eligible. * History of severe psychiatric disorders. * Prior allogeneic stem cell or organ transplantation, excluding corneal transplantation. * Prior treatment with immune modulators such as anti-PD-1, anti-PD-L1 or anti-CTLA-4 agents before enrollment. * Prior systemic anti-tumor therapy (including traditional Chinese medicines with anti-tumor indications) before enrollment. Patients are excluded if the interval between completion of prior therapy and study drug administration is less than 2 weeks or 5 half-lives of the prior drug (whichever is longer), or if adverse events related to prior therapy have not recovered to CTCAE Grade 1 or lower. * Received systemic immunosuppressive drugs within 2 weeks prior to enrollment, or anticipated need for systemic immunosuppressive drugs during the study, except for the following: 1. Intranasal, inhaled, topical or local injected corticosteroids (e.g., intra-articular injection); 2. Systemic corticosteroids at a daily dose equivalent to ≤ 10 mg prednisone; 3. Corticosteroids used for prophylaxis of hypersensitivity reactions. * Known or suspected history of hypersensitivity to chimeric/humanized antibodies or fusion proteins, or allergy to excipients of the study drug. Uncontrolled hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion or pericardial effusion. * Clinically significant cardiovascular diseases, including but not limited to acute myocardial infarction, severe/unstable angina or coronary artery bypass grafting within the previous 6 months; congestive heart failure (New York Heart Association \[NYHA\] Class \> II); uncontrolled arrhythmia or arrhythmia requiring pacemaker implantation; uncontrolled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg). Active infections: 1. Positive human immunodeficiency virus (HIV-1/2 antibody); 2. Active hepatitis C (positive HCV antibody or HCV RNA ≥ 10³ copies/mL accompanied by abnormal liver function); 3. Active tuberculosis; 4. Other uncontrolled active infections (CTCAE Version 5.0 \> Grade 2). * Other clinically significant clinical or laboratory abnormalities judged by the investigator to compromise safety assessment, such as uncontrolled diabetes, chronic kidney disease, peripheral neuropathy ≥ CTCAE Grade 2, thyroid dysfunction, etc. * Unresolved post-operative conditions, such as unhealed surgical incisions or severe post-operative complications. * Received any live attenuated vaccine within 4 weeks prior to enrollment or planned to receive such vaccines during the study. * History of alcohol, psychotropic substances or other drug abuse within the previous 6 months. * Participation in other investigational drug or medical device clinical trials within 4 weeks prior to enrollment. * Inability to comply with the study treatment or scheduled follow-up visits. * Any other conditions that make the patient ineligible for enrollment as determined by the investigator.
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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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Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
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Other studies related to the condition(s) this trial covers.
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