Hepato Cellular Carcinoma (HCC)Phase 2NCT07902258
An Exploratory Study of Single-Dose Neoadjuvant Nivolumab Without Surgical Delay in Patients With Resectable HCC
A Phase 2 study testing Nivolumab in people with Hepato Cellular Carcinoma (HCC) and Immune Checkpoint Inhibitor, run by National Taiwan University Hospital at 3 sites in Taiwan.
Trial summary
The goal of this clinical trial is to evaluate whether giving a single dose of Nivolumab (Opdivo®) before curative surgery for patients with resectable liver cancer can activate the body's immune response against the cancer and potentially reduce the risk of the cancer coming back after surgery, without delaying or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepato Cellular Carcinoma (HCC), Immune Checkpoint Inhibitor, Neoadjuvant Therapy
- What is being tested?
- Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesTaiwan
- Study dates
- 2 Nov 2026to 2 Oct 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understood and signed the informed consent form
- Age ≥ 18 years at time of signing Informed Consent Form with the ability to comply with the study protocol, in the investigator's judgment
- ECOG performance status 0 or 1
- Child-Pugh class A
- Hepatic tumor(s) with imaging features suggestive of hepatocellular carcinoma on four phase contrast-enhanced ultrasound (CEUS), multidetector computed tomography (MDCT),magnetic resonance imaging (MRI), or Primovist-MRI, as determined by the treating investigator.
- Preoperative liver function considered suitable for planned hepatectomy according to the Makuuchi criteria, including indocyanine green retention rate at 15 minutes (ICG-R15), as assessed by the treating surgeon.
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- The tumor(s) must be considered definitely resectable by the treating surgeon, and the tumor extent fulfilling all of the following criteria:
- Number of tumors ≤ 3
- Largest tumor size ≥ 5 cm (no upper limit) if no vascular invasion or portal vein thrombosis
- No minimum size limitation if Vp1-2 portal vein tumor thrombosis is present
- Absence of extrahepatic metastasis or Vp3-4 portal vein tumor thrombosis
- No prior local treatment to the tumor(s) planned for resection
- Patients with chronic hepatitis B virus (HBV) infection (HBsAg positive) must start antiviral therapy before registration
- Patients with resolved or chronic hepatitis C (HCV) infection are eligible
- Adequate hemogram and organ function:
- White blood cells (WBC) ≥ 3,000/μL and absolute neutrophil count (ANC) ≥ 1,200/μL without granulocyte colony stimulating factor (G-CSF) support within 1 week before registration
- Platelets (PLT) ≥ 60,000/μL without transfusion within 1 week before registration
- Hemoglobin (Hb) ≥ 8 g/dL without transfusion within 1 week before registration
- Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN) or calculated creatinine clearance ≥ 40 mL/min (using the Cockcroft-Gault equation)
- PT INR ≤ 1.5
- aPTT ≤ 1.5 × Upper Limit of Normal (ULN)
- Aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP) ≤ 3 × ULN
- Serum total bilirubin (T-Bil) ≤ 1.5 × ULN
- Serum albumin (Alb) ≥ 35 g/L (3.5 g/dL)
- Consent to undergo tumor biopsy if subjects have no archived tumor tissue for the largest planned resected tumor within 3 months before enrollment
- For women of childbearing potential: agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate < 1% per year for at least 6 months after the administration of nivolumab.
- A women is considered to be of childbearing potential if she has not achieved postmenopausal (no menstrual period for at least 12 consecutive months) or has not received surgical sterilization (removal of ovaries and/or uterus).
- Contraceptive methods with a failure rate of < 1% per year include: bilateral tubal ligation,male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing/copper intrauterine devices
- For men: agree to remain abstinent (refrain from heterosexual intercourse) or use a condom plus additional contraceptive methods leading to a failure rate of <1% per year (with female partner of childbearing potential), and agreement to refrain from donating sperm for at least 6 months after the administration of nivolumab.
Who cannot join
- Receiving or planning to receive other anti-cancer therapy before surgery
- Major surgical procedure within 4 weeks prior to registration
- Known human immunodeficiency virus (HIV) infection
- History of malignancies other than HCC (except those treated with curative intent with no evidence of disease for 2 years)
- Any active autoimmune disease or history of known autoimmune disease requiring systemic treatment, or a history of severe/known autoimmune disease that the investigator considers inappropriate for immunotherapy.
- Dementia, significantly altered mental status, or major systemic disease that the investigator considers inappropriate for participation
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- Prior therapy with an anti-PD-1, anti-PD-L1, anti-CTLA-4, or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Requirement of systemic corticosteroids (> 10 mg/day prednisolone equivalent) or other immunosuppressive medications (except inhaled or topical steroids) within 14 days before registration
- Prior organ allograft or allogeneic bone marrow transplantation
- Subjects with uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
- Cardiovascular disorders including symptomatic congestive heart failure, unstable angina pectoris, or serious cardiac arrhythmias
- Uncontrolled hypertension defined as sustained systolic blood pressure (BP) > 150 mmHg, or diastolic BP > 100 mm Hg despite optimal antihypertensive treatment
- Stroke (including transient ischemic attack), myocardial infarction, or other ischemic event within 6 months
- History of gastrointestinal (GI) perforation or fistula formation/bleeding or active disorders associated with high risk: tumors invading the GI tract, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic duct or common bile duct, or gastric/bowel obstruction within 6 months prior to registration
- Any clinically significant disorders that are judged by investigators to be unsuitable for the clinical trial
- Pregnant or lactating females
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan3 sites
National Taiwan University Hospital Hsin-Chu Branch(NTU BioMedical Park Hospital)
Hsinchu, 302058
Dr.Tsung-Che Wu, +886 972654621, tsungchewu8825@gmail.com
Tsung-Che C Wu, PhD
National Taiwan University Hospital
Taipei, 100
Tsung-Hao Liu, MD, +886 972651762, tsunghao.liu@gmail.com
Tsung-Hao H Liu
National Taiwan University Cancer Center
Taipei, 106
Dr.Ying-Chun Shen, +886 972655283, ycshen.daisy@gmail.com
Ying Chun C Shen, PhD
About this study
Official title: An Exploratory Study of Single-Dose Neoadjuvant Nivolumab Without Surgical Delay in Patients With Resectable Hepatocellular Carcinoma (ONESHOT STUDY)
The goal of this clinical trial is to evaluate whether giving a single dose of Nivolumab (Opdivo®) before curative surgery for patients with resectable liver cancer can activate the body's immune response against the cancer and potentially reduce the risk of the cancer coming back after surgery, without delaying or affecting the planned surgery.
The study will also evaluate whether this treatment is feasible and whether it may be effective.
Read more
Participants will:
- Complete all required examinations(e.g.: Laboratory tests, Tumor tissue biopsy, Computed tomography scan...) during the screening period
- Receive single dose of Nivolumab intravenous infusion
- Undergo surgery on its originally scheduled date
- Visit the hospital once every 4 weeks for checkups and tests after receiving Nivolumab
Read the detailed description
This is an exploratory, multicenter, single-arm study evaluating the feasibility, safety, and preliminary efficacy of a single dose of neoadjuvant nivolumab in patients with resectable hepatocellular carcinoma (HCC).
The study investigates whether a short course of preoperative immunotherapy can be incorporated into the surgical treatment pathway without compromising timely curative-intent surgery. Eligible patients will receive one intravenous dose of nivolumab, followed by planned surgical resection approximately three weeks later.
The primary objective is to assess event-free survival at one year, incorporating clinically relevant events related to surgical delay, cancellation of surgery, postoperative recurrence, or death. Secondary assessments include treatment-related adverse events, surgical outcomes, pathological tumor response, and postoperative clinical outcomes.
Exploratory translational analyses will examine treatment-associated changes in circulating immune cells and the tumor microenvironment using blood and tumor specimens collected at predefined time points.
The findings may inform the development of neoadjuvant immunotherapy strategies that minimize preoperative treatment exposure while preserving the opportunity for timely surgical resection.
- Being tested
- Nivolumab
- Keywords
- HCC, Hepato cellular carcinoma, Nivolumab, Immune checkpoint inhibitor(ICI), Neoadjuvant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called Opdivo
Nivolumab will be intravenously administered as a single dose of 240 mg with prophylactic corticosteroids consisting of intravenous betamethasone 8 mg or equivalent before nivolumab,and the curative surgery will proceed as originally scheduled whenever clinically feasible.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | A single dose of nivolumab intravenous infusion before curative surgery Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of single-dose neoadjuvant Nivolumab for resectable HCC
Feasibility is evaluated by whether curative-intent surgery could be performed without delay exceeding >14 days from the planned date.
Measured: approximately within 8 weeks after enrollment
56-week event-free survival
Prespecified events including: delay of curative-intent surgery by exceeding >14 days attributable to neoadjuvant nivolumab, surgical cancellation due to any treatment-related adverse events or clinical disease progression, postoperative disease recurrence, or death from any cause.
Measured: 56 weeks from the date of neoadjuvant Nivolumab intravenous infusion
Secondary outcomes (1)
To assess the safety and pathological response of single-dose neoadjuvant Nivolumab for resectable HCC
Adverse events, pathological response
Measured: 56 weeks from the date of neoadjuvant Nivolumab intravenous infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start2 Nov 2026 (estimated)
- Primary completion2 Sep 2028 (estimated)
- Study completion2 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepato Cellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying-Chun Shen, MD, PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902258
- Sponsor's protocol ID
- 202608144MINE
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Single-Dose Neoadjuvant Nivolumab Without Surgical Delay in Patients With Resectable Hepatocellular Carcinoma (ONESHOT STUDY)
- ClinicalTrials.gov ID
- NCT07902258
- Acronym / sponsor ID
- 202608144MINE
- Keywords
- HCC, Hepato cellular carcinoma, Nivolumab, Immune checkpoint inhibitor(ICI), Neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 2 Sep 2028 (estimated)
- Study completion
- 2 Oct 2028 (estimated)
- First posted
- 28 Oct 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.
The goal of this clinical trial is to evaluate whether giving a single dose of Nivolumab (Opdivo®) before curative surgery for patients with resectable liver cancer can activate the body's immune response against the cancer and potentially reduce the risk of the cancer coming back after surgery, without delaying or affecting the planned surgery.
The study will also evaluate whether this treatment is feasible and whether it may be effective.
Participants will:
- Complete all required examinations(e.g.: Laboratory tests, Tumor tissue biopsy, Computed tomography scan...) during the screening period
- Receive single dose of Nivolumab intravenous infusion
- Undergo surgery on its originally scheduled date
- Visit the hospital once every 4 weeks for checkups and tests after receiving Nivolumab
Detailed description
This is an exploratory, multicenter, single-arm study evaluating the feasibility, safety, and preliminary efficacy of a single dose of neoadjuvant nivolumab in patients with resectable hepatocellular carcinoma (HCC).
The study investigates whether a short course of preoperative immunotherapy can be incorporated into the surgical treatment pathway without compromising timely curative-intent surgery. Eligible patients will receive one intravenous dose of nivolumab, followed by planned surgical resection approximately three weeks later.
The primary objective is to assess event-free survival at one year, incorporating clinically relevant events related to surgical delay, cancellation of surgery, postoperative recurrence, or death. Secondary assessments include treatment-related adverse events, surgical outcomes, pathological tumor response, and postoperative clinical outcomes.
Exploratory translational analyses will examine treatment-associated changes in circulating immune cells and the tumor microenvironment using blood and tumor specimens collected at predefined time points.
The findings may inform the development of neoadjuvant immunotherapy strategies that minimize preoperative treatment exposure while preserving the opportunity for timely surgical resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: NivolumabA single dose of nivolumab intravenous infusion before curative surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Understood and signed the informed consent form
- Age ≥ 18 years at time of signing Informed Consent Form with the ability to comply with the study protocol, in the investigator's judgment
- ECOG performance status 0 or 1
- Child-Pugh class A
- Hepatic tumor(s) with imaging features suggestive of hepatocellular carcinoma on four phase contrast-enhanced ultrasound (CEUS), multidetector computed tomography (MDCT),magnetic resonance imaging (MRI), or Primovist-MRI, as determined by the treating investigator.
Key exclusion criteria (16 listed)
- Receiving or planning to receive other anti-cancer therapy before surgery
- Major surgical procedure within 4 weeks prior to registration
- Known human immunodeficiency virus (HIV) infection
- History of malignancies other than HCC (except those treated with curative intent with no evidence of disease for 2 years)
- Any active autoimmune disease or history of known autoimmune disease requiring systemic treatment, or a history of severe/known autoimmune disease that the investigator considers inappropriate for immunotherapy.
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 |
|---|---|---|
| NivolumabAlso: OpdivoNivolumab will be intravenously administered as a single dose of 240 mg with prophylactic corticosteroids consisting of intravenous betamethasone 8 mg or equivalent before nivolumab,and the curative surgery will proceed as originally scheduled whenever clinically feasible. | Drug | Single Arm |
Primary outcome
Feasibility of single-dose neoadjuvant Nivolumab for resectable HCC
Time frame: approximately within 8 weeks after enrollment
Feasibility is evaluated by whether curative-intent surgery could be performed without delay exceeding >14 days from the planned date.
56-week event-free survival
Time frame: 56 weeks from the date of neoadjuvant Nivolumab intravenous infusion
Prespecified events including: delay of curative-intent surgery by exceeding >14 days attributable to neoadjuvant nivolumab, surgical cancellation due to any treatment-related adverse events or clinical disease progression, postoperative disease recurrence, or death from any cause.
1 secondary outcome
To assess the safety and pathological response of single-dose neoadjuvant Nivolumab for resectable HCC
Time frame: 56 weeks from the date of neoadjuvant Nivolumab intravenous infusion
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 28 Oct 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.
Ying-Chun Shen, MD, PhD principal investigator
National Taiwan University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab in people with Hepato Cellular Carcinoma (HCC) and Immune Checkpoint Inhibitor, run by National Taiwan University Hospital at 3 sites in Taiwan.
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 29 inclusion and 16 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: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. 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?
Contact Ying-Chun Shen, MD, PhD (+886 972655283, yingchunshen@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of single-dose neoadjuvant Nivolumab for resectable HCC (time frame: approximately within 8 weeks after enrollment). The study lists 2 primary outcomes in all. 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 28 Oct 2026.