HCC - Hepatocellular CarcinomaPhase 2Ad-rHCCNCT07658105
Eparlitozoviril as Adjuvant Therapy for Resectable HCC With MVI
A Phase 2 study testing eparlitozoviril in people with HCC - Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Tumor recurrence is the leading cause of death and a major bottleneck for long-term survival in patients with hepatocellular carcinoma (HCC). Therefore, there is an urgent clinical need for effective postoperative adjuvant therapies to reduce postoperative recurrence and improve long-term survival, especially for HCC… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC - Hepatocellular Carcinoma
- What is being tested?
- eparlitozoviril
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2026to 30 Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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:
- Hemoglobin ≥ 90 g/L
- Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L
- Platelet count ≥ 75×10⁹/L
- Serum biochemistry:
- Albumin ≥ 28 g/L
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 × ULN
- 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
Who cannot join
- 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.
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- 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:
- Intranasal, inhaled, topical or local injected corticosteroids (e.g., intra-articular injection);
- Systemic corticosteroids at a daily dose equivalent to ≤ 10 mg prednisone;
- 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:
- Positive human immunodeficiency virus (HIV-1/2 antibody);
- Active hepatitis C (positive HCV antibody or HCV RNA ≥ 10³ copies/mL accompanied by abnormal liver function);
- Active tuberculosis;
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
About this study
Official title: Eparlitozoviril (Apalolithovolrelimab) as Adjuvant Therapy After Resection for Resectable Hepatocellular Carcinoma With Microvascular Invasion (MVI): A Prospective, Single-Center, Phase II Cohort Study
Tumor recurrence is the leading cause of death and a major bottleneck for long-term survival in patients with hepatocellular carcinoma (HCC). Therefore, there is an urgent clinical need for effective postoperative adjuvant therapies to reduce postoperative recurrence and improve long-term survival, especially for HCC patients with high-risk factors. However, no standard adjuvant treatment regimen has been established so far, and domestic and international guidelines have not reached a consensus on relevant recommendations. It is generally recognized that postoperative antiviral therapy with nucleoside analogues and interferon yields definite benefits for patients with HBV- or HCV-related HCC, particularly those in Asian populations. Some interventions have been proven ineffective. For instance, the majority of studies have demonstrated that postoperative chemotherapy fails to bring survival benefits and may even lead to worse prognosis in HCC patients. Besides, multiple treatment modalities including transarterial chemoembolization (TACE), radiotherapy, targeted therapy and immunotherapy are still under investigation.
MVI has been well documented as a strong high-risk factor for postoperative recurrence of HCC. The presence of MVI indicates the capacity of tumor cells for local invasion and distant metastasis. According to the number and location of microscopic tumor foci observed under pathological microscopy, MVI is classified into three grades: (1) M0: No microscopic tumor foci detected; (2) M1: No more than 5 microscopic foci within 1 cm adjacent to the primary tumor; (3) M2: More than 5 microscopic foci or foci located beyond 1 cm from the primary tumor. A retrospective study from Zhongshan Hospital, Fudan University enrolled 661 HCC patients who developed recurrence within 5 years after curative resection, and reported that the rate of MVI positivity was 31.6% among these recurrent cases. Another retrospective study conducted at Eastern Hepatobiliary Surgery Hospital of Shanghai involving 496 HCC patients showed that patients with MVI had significantly lower recurrence-free survival (RFS) and overall survival (OS) compared with those without MVI. A series of studies have been carried out to explore postoperative adjuvant treatments for resectable HCC patients complicated with MVI. A phase III randomized controlled trial conducted by Wei et al. revealed that for patients with single resectable HCC (tumor ≥ 5 cm) combined with MVI, postoperative adjuvant TACE (1 to 2 cycles) achieved a median disease-free survival (DFS) of 17.45 months (95% CI: 11.99-29.14), versus 9.27 months (95% CI: 6.05-13.70) in the active surveillance group (HR=0.70, p=0.020). In addition, Li et al. evaluated the efficacy of postoperative adjuvant FOLFOX-based hepatic arterial infusion chemotherapy (HAIC) in resectable HCC patients with MVI. The results demonstrated that adjuvant HAIC could significantly prolong DFS, with a median DFS of 20.3 months versus 10.0 months (p=0.001). Collectively, active postoperative intervention is clinically meaningful for resectable HCC patients with MVI.
Read more
In recent years, tumor immunotherapy represented by immune checkpoint inhibitors, including antibodies against programmed death-1 (PD-1), programmed death ligand-1 (PD-L1) and cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), has gradually become a key therapeutic strategy for malignancies. Tumor cells can inhibit T cell activity and evade immune surveillance by expressing immune checkpoint ligands. Blockade of these immune checkpoints can enhance the proliferation, survival and cytotoxicity of T cells, thereby exerting anti-tumor effects. Anti-PD-1/PD-L1 antibodies have exhibited favorable efficacy in a variety of solid tumors.
Given the high postoperative recurrence risk of resectable HCC with MVI and the lack of consensus on standard adjuvant regimens, as well as the proven efficacy of PD-1 monoclonal antibodies and HAIC in this setting in previous randomized controlled trials, we designed a prospective, single-center, open-label, phase II cohort study. This study aims to preliminarily evaluate the efficacy and safety of eparlitozoviril (dual PD-1/CTLA-4 immunotherapy), compared with active surveillance, in resectable HCC patients with MVI. The findings of this study may provide evidence for the optimization of postoperative adjuvant treatment for HCC.
- Conditions
- HCC - Hepatocellular Carcinoma
- Being tested
- eparlitozoviril, Control group
- Keywords
- Hepatocellular Carcinoma, eparlitozoviril, adjuvant treatment, dual PD-1/CTLA-4 immunotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eparlitozovirilDrug
Eparlitozoviril: 7.5 mg/kg iv q3w. Treatment duration: up to 6 months, or until disease recurrence, death or intolerable AEs.
Control groupOther
Active surveillance, every 3 months, until disease recurrence, death.
| Study group | Role | What they receive |
|---|---|---|
| immunotherapy group | Experimental | eparlitozoviril (dual PD-1/CTLA-4 immunotherapy) Receives: Drug: eparlitozoviril |
| Control group | Active comparator | active surveillance Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year recurrence-free survival (RFS) rate
The percentage of participants who remain free of disease recurrence at 1 year after treatment.
Measured: Time from treatment start to disease recurrence, at 1 year.
Secondary outcomes (4)
2-year recurrence-free survival (RFS) rate
The percentage of participants who remain free of disease recurrence at 2 year after treatment.
Measured: Time from treatment start to disease recurrence, at 2 year.
Overall survival (OS)
The total time from study enrollment to death from any cause.
Measured: Time from treatment initiation to death from any cause, an average of 3 years.
Adverse events (AEs)
AEs will be graded per NCI-CTCAE v5.0. Evaluate overall AE rate, grade-specific AE rate, Grade ≥3 AE rate and SAE rate.
Measured: From enrollment to the end of treatment, up to 12 months
Time to recurrence (TTR)
The time interval between treatment completion and the first detection of disease recurrence.
Measured: From treatment start to disease recurrence, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start12 Jun 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658105
- Sponsor's protocol ID
- E20251316A
- Acronym
- Ad-rHCC
- Status last verified
- Mar 2026
- First submitted
- 14 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eparlitozoviril (Apalolithovolrelimab) as Adjuvant Therapy After Resection for Resectable Hepatocellular Carcinoma With Microvascular Invasion (MVI): A Prospective, Single-Center, Phase II Cohort Study
- ClinicalTrials.gov ID
- NCT07658105
- Acronym / sponsor ID
- Ad-rHCC / E20251316A
- Conditions
- HCC - Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, eparlitozoviril, adjuvant treatment, dual PD-1/CTLA-4 immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tumor recurrence is the leading cause of death and a major bottleneck for long-term survival in patients with hepatocellular carcinoma (HCC). Therefore, there is an urgent clinical need for effective postoperative adjuvant therapies to reduce postoperative recurrence and improve long-term survival, especially for HCC patients with high-risk factors. However, no standard adjuvant treatment regimen has been established so far, and domestic and international guidelines have not reached a consensus on relevant recommendations. It is generally recognized that postoperative antiviral therapy with nucleoside analogues and interferon yields definite benefits for patients with HBV- or HCV-related HCC, particularly those in Asian populations. Some interventions have been proven ineffective. For instance, the majority of studies have demonstrated that postoperative chemotherapy fails to bring survival benefits and may even lead to worse prognosis in HCC patients. Besides, multiple treatment modalities including transarterial chemoembolization (TACE), radiotherapy, targeted therapy and immunotherapy are still under investigation.
MVI has been well documented as a strong high-risk factor for postoperative recurrence of HCC. The presence of MVI indicates the capacity of tumor cells for local invasion and distant metastasis. According to the number and location of microscopic tumor foci observed under pathological microscopy, MVI is classified into three grades: (1) M0: No microscopic tumor foci detected; (2) M1: No more than 5 microscopic foci within 1 cm adjacent to the primary tumor; (3) M2: More than 5 microscopic foci or foci located beyond 1 cm from the primary tumor. A retrospective study from Zhongshan Hospital, Fudan University enrolled 661 HCC patients who developed recurrence within 5 years after curative resection, and reported that the rate of MVI positivity was 31.6% among these recurrent cases. Another retrospective study conducted at Eastern Hepatobiliary Surgery Hospital of Shanghai involving 496 HCC patients showed that patients with MVI had significantly lower recurrence-free survival (RFS) and overall survival (OS) compared with those without MVI. A series of studies have been carried out to explore postoperative adjuvant treatments for resectable HCC patients complicated with MVI. A phase III randomized controlled trial conducted by Wei et al. revealed that for patients with single resectable HCC (tumor ≥ 5 cm) combined with MVI, postoperative adjuvant TACE (1 to 2 cycles) achieved a median disease-free survival (DFS) of 17.45 months (95% CI: 11.99-29.14), versus 9.27 months (95% CI: 6.05-13.70) in the active surveillance group (HR=0.70, p=0.020). In addition, Li et al. evaluated the efficacy of postoperative adjuvant FOLFOX-based hepatic arterial infusion chemotherapy (HAIC) in resectable HCC patients with MVI. The results demonstrated that adjuvant HAIC could significantly prolong DFS, with a median DFS of 20.3 months versus 10.0 months (p=0.001). Collectively, active postoperative intervention is clinically meaningful for resectable HCC patients with MVI.
In recent years, tumor immunotherapy represented by immune checkpoint inhibitors, including antibodies against programmed death-1 (PD-1), programmed death ligand-1 (PD-L1) and cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4), has gradually become a key therapeutic strategy for malignancies. Tumor cells can inhibit T cell activity and evade immune surveillance by expressing immune checkpoint ligands. Blockade of these immune checkpoints can enhance the proliferation, survival and cytotoxicity of T cells, thereby exerting anti-tumor effects. Anti-PD-1/PD-L1 antibodies have exhibited favorable efficacy in a variety of solid tumors.
Given the high postoperative recurrence risk of resectable HCC with MVI and the lack of consensus on standard adjuvant regimens, as well as the proven efficacy of PD-1 monoclonal antibodies and HAIC in this setting in previous randomized controlled trials, we designed a prospective, single-center, open-label, phase II cohort study. This study aims to preliminarily evaluate the efficacy and safety of eparlitozoviril (dual PD-1/CTLA-4 immunotherapy), compared with active surveillance, in resectable HCC patients with MVI. The findings of this study may provide evidence for the optimization of postoperative adjuvant treatment for HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immunotherapy group | Experimental | Drug: eparlitozovirileparlitozoviril (dual PD-1/CTLA-4 immunotherapy) |
| Control group | Active comparator | Other: Control groupactive surveillance |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eparlitozovirilEparlitozoviril: 7.5 mg/kg iv q3w. Treatment duration: up to 6 months, or until disease recurrence, death or intolerable AEs. | Drug | immunotherapy group |
| Control groupActive surveillance, every 3 months, until disease recurrence, death. | Other | Control group |
Primary outcome
1-year recurrence-free survival (RFS) rate
Time frame: Time from treatment start to disease recurrence, at 1 year.
The percentage of participants who remain free of disease recurrence at 1 year after treatment.
4 secondary outcomes
2-year recurrence-free survival (RFS) rate
Time frame: Time from treatment start to disease recurrence, at 2 year.
Overall survival (OS)
Time frame: Time from treatment initiation to death from any cause, an average of 3 years.
Adverse events (AEs)
Time frame: From enrollment to the end of treatment, up to 12 months
Time to recurrence (TTR)
Time frame: From treatment start to disease recurrence, an average of 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing eparlitozoviril in people with HCC - Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year recurrence-free survival (RFS) rate (time frame: Time from treatment start to disease recurrence, at 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.