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New immunotherapy combo aims to stop liver cancer return after surgery

NCT ID NCT07658105

What the study statuses mean

This study's is highlighted.

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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

Details not published
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This status has not been confirmed recently, so it may be out of date.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 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

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.

Started

Jun 2026

Expected to finish

Jun 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 to 75 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: * 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

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

More trials for these conditions

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