Hepatocellular CarcinomaPhase 2NCT06467799
Neoadjuvant HAIC and PD-1 Plus Adjuvant PD-1 for High-risk Recurrent HCC
A Phase 2 study testing Neoadjuvant HAIC and PD-1 Plus Adjuvant PD-1 in people with Hepatocellular Carcinoma and Beyond Milan Criteria, run by Sun Yat-sen University at 1 site in China.
Trial summary
Surgical resection is the primary curative treatment for patients with hepatocellular carcinoma (HCC), with a 5-year overall survival rate of 60-80% post-surgery. Therefore, guidelines recommend surgical resection as the first-line choice for early to mid-stage HCC (CNLC stages IA-IIA or BCLC stages A/B) patients with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Beyond Milan Criteria
- What is being tested?
- Neoadjuvant HAIC and PD-1 Plus Adjuvant PD-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 1 Sep 2027
- 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
- Newly diagnosed and untreated hepatocellular carcinoma (clinical diagnostic criteria based on the " Chinese Guidelines for the Diagnosis and Treatment of Hepatocellular Carcinoma (2024 Edition) " formulated by the National Health Commission of China and the Barcelona Clinic Liver Cancer (BCLC) strategy for prognosis prediction and treatment recommendation of the European Association for the Study of the Liver (EASL));
- Tumor staging: beyond Milan criteria (single tumor >5 cm, or 2-3 tumors with the largest diameter >3 cm), resectable CNLC stage Ib/IIa hepatocellular carcinoma;
- No tumor thrombus, distant metastasis, or lymph node metastasis;
- Normal liver volume ≥ 700 cc, estimated residual liver volume >40% after resection;
- Patient KPS ≥ 90;
- Liver function Child-Pugh class A;
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- Estimated survival of more than 6 months;
- Function of important organs meets the following requirements: white blood cells ≥ 4.0×10^9/l, neutrophils ≥ 1.5×10^9/l, platelets ≥ 80.0×10^9/l, hemoglobin ≥ 90 g/l; serum albumin ≥ 2.8 g/dl; total bilirubin ≤ 1.5 × ULN, ALT/AST/ALP ≤ 2.5 × ULN; serum creatinine ≤ 1.5 × ULN or creatinine clearance rate > 60 mL/min; no severe organic diseases;
- The subject must be able to understand and voluntarily sign a written informed consent form, and must sign the informed consent form prior to any specific procedure of the study, agreeing to comply with the medication and postoperative follow-up requirements as designed in this study.
Who cannot join
- Combined with severe impairment of functions of other important organs such as heart, lungs, and kidneys; active infections other than viral hepatitis or other serious comorbid conditions, making the patient unable to tolerate treatment;
- Contraindications to surgical resection and immunotherapy;
- History of other malignant tumors;
- Combined with immunological diseases or other conditions requiring long-term steroid treatment;
- Known or suspected allergy to the study drug or any drugs administered in connection with this trial;
- History of organ transplantation;
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- Pregnant or breastfeeding women;
- Other factors that may affect patient enrollment and assessment outcomes;
- Refusal to follow-up according to the requirements set by the study protocol, and refusal to sign the informed consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Yaojun Zhang, +86 13719433968
zhangyuj@sysucc.org.cn
About this study
Official title: Neoadjuvant Hepatic Arterial Infusion Chemotherapy Plus Tislelizumab Combined With Adjuvant Tislelizumab in Preventing Postoperative Recurrence for High-risk Hepatocellular Carcinoma: a Prospective, Single-arm, Phase II Clinical Study
Surgical resection is the primary curative treatment for patients with hepatocellular carcinoma (HCC), with a 5-year overall survival rate of 60-80% post-surgery. Therefore, guidelines recommend surgical resection as the first-line choice for early to mid-stage HCC (CNLC stages IA-IIA or BCLC stages A/B) patients with well liver reserve function. However, the high postoperative recurrence rate is the main factor limiting long-term survival in HCC patients, with literature reporting recurrence rates exceeding 70%. Among these, half of the patients experience recurrence within two years post-surgery, imposing a heavy burden on patients' physical and mental health as well as on societal medical resources. Adopting effective treatment to improve surgical curability and reduce postoperative recurrence rates is one of the current research hotspots.
Recent studies from the investigators' center indicate that hepatic arterial infusion chemotherapy (HAIC) and immunotherapy can provide definite efficacy for patients with advanced HCC, extending their survival time. Mechanistically, chemotherapy and immunotherapy have synergistic effects: tumor cell necrosis induced by chemotherapy can promote immune activation, while cytokines and neutralizing antibodies secreted by immune cells can enhance the toxicity of chemotherapeutic drugs.
Therefore, this study aims to conduct a prospective, single-arm, phase II clinical study, targeting HCC patients with high-risk recurrence factors, to evaluate whether neoadjuvant HAIC combined with a PD-1 monoclonal antibody (Tislelizumab) followed by adjuvant Tislelizumab post-surgery can reduce postoperative recurrence rates in HCC patients. The primary endpoint is the 1-year recurrence-free survival (RFS) rate post-surgery, while secondary endpoints include the objective response rate (ORR) of neoadjuvant therapy, the incidence of perioperative complications, the incidence of treatment-related adverse events, overall survival (OS) time, pathological complete response (pCR) rate of neoadjuvant therapy, and major pathological response (MPR) of neoadjuvant therapy. The investigators aim to comprehensively assess the efficacy and safety of neoadjuvant HAIC plus PD-1 and adjuvant PD-1 in the perioperative treatment of HCC.
- Conditions
- Hepatocellular Carcinoma, Beyond Milan Criteria
- Being tested
- Neoadjuvant HAIC and PD-1 Plus Adjuvant PD-1
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant HAIC and PD-1 Plus Adjuvant PD-1Drug
Patients will first receive two cycles of FOLFOX-HAIC combined with tislelizumab as neoadjuvant therapy, with a 3-week interval between cycles. Two weeks after completing the neoadjuvant therapy, imaging assessments will be conducted to evaluate treatment efficacy and surgical feasibility. Surgical resection should be performed within two weeks following the imaging assessment. Four weeks post-resection, patients will undergo a follow-up evaluation to assess postoperative recovery and determine the presence of any residual tumor. If no residual or recurrent tumor is detected, adjuvant therapy with tislelizumab will commence (every three weeks, for a total of four cycles).
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Two cycles of FOLFOX-HAIC combined with tislelizumab as neoadjuvant therapy, followed by surgical resection and four cycles of adjuvant tislelizumab. Receives: Drug: Neoadjuvant HAIC and PD-1 Plus Adjuvant PD-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence free survival, RFS
RFS is defined as the time from treatment to post-resection tumor recurrence or death from any cause.
Measured: From date of treatment beginning until the date of first documented tumor recurrence or date of death from any cause, whichever came first, assessed up to 1 years
Secondary outcomes (5)
objective response rate，ORR
The ratio of patients achieving the best efficacy of neoadjuvant therapy, including complete response (CR) and partial response (PR), to all patients.
Measured: From date of neoadjuvant treatment beginning until the date of neoadjuvant treatment completion, up to 1 year.
pathological complete response，pCR
The ratio of patients with no viable tumor cells in the pathology after resection to all patients undergoing surgical resection.
Measured: From date of neoadjuvant treatment beginning until the date of surgical resection completion, , up to 1 year.
overall survival, OS
OS is defined as the time from randomization to death from any cause.
Measured: From date of treatment beginning until the date of death from any cause, assessed up to 1 years.
perioperative complication rate
Perioperative complication includes intraoperative complications such as bleeding and transfusion, extensive adhesions, diaphragm resection, prolonged surgery time, etc., as well as postoperative complications such as bleeding, infection, bile leakage, liver dysfunction, etc.
Measured: The period from the start of surgery to the patient's discharge from hospital, up to 1 year.
Incidence of adverse events (safety )
Treatment-related adverse events are evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE 5.0).
Measured: From date of neoadjuvant treatment beginning until the date of adjuvant treatment completion, up to 2 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start1 Sep 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Min-Shan, Sun Yat-sen University
- Investigators
- Yaojun Zhang, MD, PHD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467799
- Sponsor's protocol ID
- B2024-211-01
- Status last verified
- Sep 2025
- First submitted
- 13 Jun 2024
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Hepatic Arterial Infusion Chemotherapy Plus Tislelizumab Combined With Adjuvant Tislelizumab in Preventing Postoperative Recurrence for High-risk Hepatocellular Carcinoma: a Prospective, Single-arm, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT06467799
- Acronym / sponsor ID
- B2024-211-01
- Conditions
- Hepatocellular Carcinoma, Beyond Milan Criteria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 21 Jun 2024 (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.
Surgical resection is the primary curative treatment for patients with hepatocellular carcinoma (HCC), with a 5-year overall survival rate of 60-80% post-surgery. Therefore, guidelines recommend surgical resection as the first-line choice for early to mid-stage HCC (CNLC stages IA-IIA or BCLC stages A/B) patients with well liver reserve function. However, the high postoperative recurrence rate is the main factor limiting long-term survival in HCC patients, with literature reporting recurrence rates exceeding 70%. Among these, half of the patients experience recurrence within two years post-surgery, imposing a heavy burden on patients' physical and mental health as well as on societal medical resources. Adopting effective treatment to improve surgical curability and reduce postoperative recurrence rates is one of the current research hotspots.
Recent studies from the investigators' center indicate that hepatic arterial infusion chemotherapy (HAIC) and immunotherapy can provide definite efficacy for patients with advanced HCC, extending their survival time. Mechanistically, chemotherapy and immunotherapy have synergistic effects: tumor cell necrosis induced by chemotherapy can promote immune activation, while cytokines and neutralizing antibodies secreted by immune cells can enhance the toxicity of chemotherapeutic drugs.
Therefore, this study aims to conduct a prospective, single-arm, phase II clinical study, targeting HCC patients with high-risk recurrence factors, to evaluate whether neoadjuvant HAIC combined with a PD-1 monoclonal antibody (Tislelizumab) followed by adjuvant Tislelizumab post-surgery can reduce postoperative recurrence rates in HCC patients. The primary endpoint is the 1-year recurrence-free survival (RFS) rate post-surgery, while secondary endpoints include the objective response rate (ORR) of neoadjuvant therapy, the incidence of perioperative complications, the incidence of treatment-related adverse events, overall survival (OS) time, pathological complete response (pCR) rate of neoadjuvant therapy, and major pathological response (MPR) of neoadjuvant therapy. The investigators aim to comprehensively assess the efficacy and safety of neoadjuvant HAIC plus PD-1 and adjuvant PD-1 in the perioperative treatment of HCC.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: Neoadjuvant HAIC and PD-1 Plus Adjuvant PD-1Two cycles of FOLFOX-HAIC combined with tislelizumab as neoadjuvant therapy, followed by surgical resection and four cycles of adjuvant tislelizumab. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Newly diagnosed and untreated hepatocellular carcinoma (clinical diagnostic criteria based on the " Chinese Guidelines for the Diagnosis and Treatment of Hepatocellular Carcinoma (2024 Edition) " formulated by the National Health Commission of China and the Barcelona Clinic Liver Cancer (BCLC) strategy for prognosis prediction and treatment recommendation of the European Association for the Study of the Liver (EASL));
- Tumor staging: beyond Milan criteria (single tumor >5 cm, or 2-3 tumors with the largest diameter >3 cm), resectable CNLC stage Ib/IIa hepatocellular carcinoma;
- No tumor thrombus, distant metastasis, or lymph node metastasis;
- Normal liver volume ≥ 700 cc, estimated residual liver volume >40% after resection;
- Patient KPS ≥ 90;
Key exclusion criteria (9 listed)
- Combined with severe impairment of functions of other important organs such as heart, lungs, and kidneys; active infections other than viral hepatitis or other serious comorbid conditions, making the patient unable to tolerate treatment;
- Contraindications to surgical resection and immunotherapy;
- History of other malignant tumors;
- Combined with immunological diseases or other conditions requiring long-term steroid treatment;
- Known or suspected allergy to the study drug or any drugs administered in connection with this trial;
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 |
|---|---|---|
| Neoadjuvant HAIC and PD-1 Plus Adjuvant PD-1Patients will first receive two cycles of FOLFOX-HAIC combined with tislelizumab as neoadjuvant therapy, with a 3-week interval between cycles. Two weeks after completing the neoadjuvant therapy, imaging assessments will be conducted to evaluate treatment efficacy and surgical feasibility. Surgical resection should be performed within two weeks following the imaging assessment. Four weeks post-resection, patients will undergo a follow-up evaluation to assess postoperative recovery and determine the presence of any residual tumor. If no residual or recurrent tumor is detected, adjuvant therapy with tislelizumab will commence (every three weeks, for a total of four cycles). | Drug | Experimental arm |
Primary outcome
recurrence free survival, RFS
Time frame: From date of treatment beginning until the date of first documented tumor recurrence or date of death from any cause, whichever came first, assessed up to 1 years
RFS is defined as the time from treatment to post-resection tumor recurrence or death from any cause.
5 secondary outcomes
objective response rate，ORR
Time frame: From date of neoadjuvant treatment beginning until the date of neoadjuvant treatment completion, up to 1 year.
pathological complete response，pCR
Time frame: From date of neoadjuvant treatment beginning until the date of surgical resection completion, , up to 1 year.
overall survival, OS
Time frame: From date of treatment beginning until the date of death from any cause, assessed up to 1 years.
perioperative complication rate
Time frame: The period from the start of surgery to the patient's discharge from hospital, up to 1 year.
Incidence of adverse events (safety )
Time frame: From date of neoadjuvant treatment beginning until the date of adjuvant treatment completion, up to 2 year.
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 29 Sep 2025.
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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.
Yaojun Zhang, MD, PHD principal investigator
Sun Yat-Sen University Cancer Center
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 Neoadjuvant HAIC and PD-1 Plus Adjuvant PD-1 in people with Hepatocellular Carcinoma and Beyond Milan Criteria, run by Sun Yat-sen University 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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 29 Sep 2025. 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?
Contact Yaojun Zhang, MD, PHD (+8613719433968, zhangyuj@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence free survival, RFS (time frame: From date of treatment beginning until the date of first documented tumor recurrence or date of death from any cause, whichever came first, assessed up to 1 years). 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 29 Sep 2025.