Hepatocellular Carcinoma (HCC)Phase 2NCT07644208
PD-1/IL-2 Bispecific Antibody as Neoadjuvant Therapy for Early Recurrent Hepatocellular Carcinoma After Curative Hepatectomy
A Phase 2 study testing PD-1/IL-2 Bispecific Antibody Fusion Protein in people with Hepatocellular Carcinoma (HCC), run by Shanghai Zhongshan Hospital.
Trial summary
This is a single-arm, phase II clinical study designed to evaluate the efficacy and safety of a recombinant PD-1/IL-2 bispecific antibody, as neoadjuvant therapy in hepatocellular carcinoma (HCC) patients who experienced early recurrence after curative hepatectomy and were suitable for repeat surgical resection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- PD-1/IL-2 Bispecific Antibody Fusion Protein
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 1 Apr 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
- Have signed the written informed consent form and be able to comply with all scheduled visits and study procedures specified in the protocol.
- Aged between 18 and 75 years old (inclusive), with no restriction on gender.
- Diagnosed with hepatocellular carcinoma (HCC) confirmed by histopathology or cytology, or meeting the clinical diagnostic criteria for HCC formulated by the American Association for the Study of Liver Diseases (AASLD) or the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer.
- Must provide tumor tissue specimens obtained from the initial surgical resection during the screening period.
- Have a history of curative hepatectomy for HCC, with pathologically confirmed tumor recurrence occurring 3 months to 2 years after surgery. Candidates shall be assessed by a multidisciplinary team (MDT) and meet all the following criteria for repeat resection:
- CNLC stage Ia-Ib or IIa-IIb, with recurrent lesions confined to one hepatic lobe; Adequate liver function reserve with Child-Pugh Class A; The volume of the future liver remnant (FLR) accounts for ≥40% of the standard liver volume (SLV) in patients with chronic liver disease, liver parenchymal damage or liver cirrhosis, or ≥30% in patients without liver fibrosis or cirrhosis; No vascular tumor thrombus; No extrahepatic metastasis.
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- Have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), and the lesion has not received any local therapy.
- Have adequate organ and bone marrow function. Laboratory test results obtained within 7 days prior to enrollment shall meet the following requirements. No blood products, erythropoietin, colony-stimulating factors, thrombopoietin, albumin or other parenteral corrective medications are allowed within 14 days before laboratory testing:
- Hematology: Hemoglobin (HGB) ≥ 90 g/L; Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹/L; Platelet (PLT) count ≥ 100×10⁹/L.
- Liver function: Total Bilirubin (TBIL) ≤ 1.5 × Upper Limit of Normal (ULN). Participants with TBIL > 1.5 × ULN but conjugated bilirubin ≤ ULN are also eligible; Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 5 × ULN; Alkaline Phosphatase (ALP) ≤ 4 × ULN; Serum albumin ≥ 30 g/L.
- Renal function: Serum Creatinine (Cr) ≤ 1.5 × ULN, or Creatinine Clearance (CCr) ≥ 50 mL/min (calculated by the Cockcroft-Gault formula using actual body weight). Urinalysis shows urine protein < 2+. For participants with urine protein ≥ 2+ at baseline, the 24-hour urinary protein quantification shall be < 1 g.
- Coagulation function: International Normalized Ratio (INR) ≤ 1.5 × ULN; Partial Thromboplastin Time (PTT) / Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 × ULN. Participants on stable-dose anticoagulant therapy shall remain within the expected therapeutic range of the prescribed anticoagulants.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
- Expected survival time of no less than 6 months.
- Female participants of childbearing potential and male participants whose partners are of childbearing potential must agree to use effective contraception throughout the treatment period and for 6 months after the last study drug administration.
Who cannot join
- Histologically or cytologically confirmed diagnosis of tumors containing components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, mixed carcinoma, and intrahepatic cholangiocarcinoma.
- Prior treatment with anti-PD-1/PD-L1 agents or other antitumor immunotherapies.
- Presence of unresolved Grade >1 toxicities related to any previous antitumor therapy (persistent Grade 2 alopecia, anemia, peripheral neuropathy, electrolyte abnormalities manageable with treatment, and endocrine disorders well-controlled with hormone replacement therapy are excluded).
- History of hepatic encephalopathy or seizures; presence of active, newly diagnosed or untreated central nervous system metastases, spinal cord compression, carcinomatous meningitis or leptomeningeal metastases.
- Presence of clinically significant cardiovascular and cerebrovascular diseases, including:
- Severe conduction disorders (e.g., third-degree atrioventricular block);
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- Symptomatic, clinically unstable arrhythmias or arrhythmias requiring clinical intervention;
- Corrected QT interval (QTc, calculated via Fridericia's formula) ≥ 480 ms;
- Uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg despite optimal medical treatment), or history of hypertensive crisis or hypertensive encephalopathy;
- History of myocarditis;
- Symptomatic congestive heart failure (New York Heart Association Class II-IV) or left ventricular ejection fraction (LVEF) < 50% on cardiac ultrasonography;
- Any arterial thrombosis, embolism or ischemic event within 6 months prior to the first study drug administration, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack;
- History of deep vein thrombosis, pulmonary embolism or other severe thromboembolic events within 6 months before enrollment (Thrombosis related to implantable venous access ports, catheters or superficial phlebitis is not defined as severe thromboembolism). Patients with adequately treated deep vein thrombosis may be enrolled if deemed stable by the investigator.
- Current or prior history of interstitial pneumonia, pulmonary fibrosis, pneumoconiosis, drug-induced pneumonitis, radiation pneumonitis, severe pulmonary dysfunction or other restrictive lung diseases requiring corticosteroids or other treatments.
- History of severe or uncontrolled allergic diathesis, drug allergy, asthma or atopic dermatitis.
- Known allergy to IL-2, sintilimab, other monoclonal antibodies or their excipients.
- Symptomatic pleural effusion, ascites or pericardial effusion requiring repeated drainage (Patients with effusions not requiring drainage or with no obvious reaccumulation within 3 days after drainage discontinuation are eligible for enrollment).
- History of active autoimmune diseases requiring systemic therapy (e.g., disease-modifying drugs, corticosteroids or immunosuppressants) within 2 years prior to the first drug administration. Replacement therapies (e.g., levothyroxine, insulin, physiological corticosteroids for adrenal or pituitary insufficiency) are not regarded as systemic treatment.
- History of allogeneic organ transplantation (including liver transplantation) or allogeneic hematopoietic stem cell transplantation.
- Active uncontrolled bleeding, known bleeding diathesis, unhealed severe wounds, ulcers or fractures; history of esophagogastric variceal bleeding caused by portal hypertension within the preceding 6 months. Grade 3 varices confirmed by endoscopy within 3 months before the first administration. Patients with evidence of portal hypertension (including splenomegaly on imaging) with high bleeding risk assessed by investigators shall undergo endoscopic evaluation.
- Presence of major gastrointestinal diseases within 6 months prior to or at the time of drug administration, including gastrointestinal perforation, severe gastrointestinal fistula (with severely impaired gastrointestinal function or requiring invasive intervention), history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection complicated with chronic diarrhea), Crohn's disease, ulcerative colitis or long-standing chronic diarrhea.
- Confirmed HIV positivity or history of acquired immunodeficiency syndrome (AIDS); active hepatitis B or hepatitis C (HCV), or history of infection with the above viruses.
- For patients positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), HBV DNA testing is required. Those with HBV DNA ≤ 10⁴ copies/mL, ≤ 2000 IU/mL or below the lower limit of quantification are eligible. HBsAg-positive patients must receive antiviral therapy throughout the study with regular HBV DNA monitoring.
- Patients with positive HCV serology but undetectable HCV RNA are permitted to enroll.
- Patients who have completed anti-HCV treatment with undetectable viral load are eligible for enrollment.
- Active tuberculosis, patients currently receiving anti-tuberculosis treatment or those who received anti-tuberculosis therapy within 1 year before the first drug administration; patients with active syphilis requiring treatment.
- Severe, active or uncontrolled infections, infections requiring intravenous systemic antibiotics, or unexplained fever (>38 °C) within 2 weeks prior to the first study drug administration.
- Diagnosis of other pathologically confirmed malignant tumors within 5 years before enrollment. Exceptions include radically cured basal cell carcinoma, squamous cell carcinoma of the skin, completely resected carcinoma in situ, radically resected local prostate cancer and papillary thyroid carcinoma, as well as other malignancies with complete remission, no evidence of active disease for at least 2 years prior to enrollment and extremely low recurrence risk.
- Excluded medications and treatments (None of the following interventions are allowed):
- a Last dose of antitumor therapies administered within 4 weeks before the first study drug: systemic chemotherapy (2-week washout period for oral fluoropyrimidines), endocrine therapy, targeted therapy (washout period of 2 weeks or 5 half-lives, whichever is longer), immunotherapy and tumor embolization. Traditional Chinese medicines for antitumor indications or immunomodulatory drugs (e.g., thymosin, interferon, interleukin) last administered within 1 week prior to the first dose.
- Participation in any medical device or other interventional clinical trials within 2 weeks before the first dose or during the study period.
- Palliative radiotherapy administered within 2 weeks before the first dose. d. Live vaccines for infectious disease prophylaxis administered within 4 weeks before the first dose.
- Immunosuppressants or systemic corticosteroids (equivalent to >10 mg prednisone per day) administered within 2 weeks before the first dose.
- Major surgery performed within 4 weeks before the first dose.
- Pregnant or breastfeeding females, or females planning to become pregnant before drug administration, during treatment or within 6 months after the last dose of study drug.
- Any concomitant disease, prior treatment, abnormal laboratory findings, history of substance abuse or current substance use, which in the investigator's judgment may compromise patient safety, hinder informed consent acquisition, affect treatment compliance or interfere with the safety assessment of the study drug.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II Study to Evaluate the Efficacy and Safety of PD-1/IL-2 Bispecific Antibody as Neoadjuvant Therapy in Hepatocellular Carcinoma Patients With Early Recurrence After Curative Hepatectomy and Eligible for Re-resection
This is a single-arm, phase II clinical study designed to evaluate the efficacy and safety of a recombinant PD-1/IL-2 bispecific antibody, as neoadjuvant therapy in hepatocellular carcinoma (HCC) patients who experienced early recurrence after curative hepatectomy and were suitable for repeat surgical resection.
A total of approximately 30 eligible participants are planned to be enrolled. All patients will receive neoadjuvant treatment with PD-1/IL-2 bispecific antibody for 3 cycles. Curative re-resection will be performed 2 to 7 weeks after the last dose of PD-1/IL-2 bispecific antibody for patients with resectable lesions confirmed by imaging assessment. Tumor evaluation will be conducted per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) throughout the study. Postoperative pathological assessment and long-term follow-up will be implemented after surgery.
Read more
The primary endpoint is the major pathological response (MPR) rate. Secondary endpoints include complete pathological response (pCR) rate, event-free survival (EFS), overall survival (OS), R0 resection rate, objective response rate (ORR), disease control rate (DCR), and the safety and tolerability profile . Exploratory endpoints aim to analyze the correlation between biomarkers (e.g., PD-L1 expression, tumor microenvironment) and treatment efficacy.
This study intends to explore the clinical value of PD-1/IL-2 bispecific antibody in the neoadjuvant setting for recurrent resectable HCC, and provide evidence for its clinical application in this patient population.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- PD-1/IL-2 Bispecific Antibody Fusion Protein
- Keywords
- Hepatocellular Carcinoma, Neoadjuvant Therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1/IL-2 Bispecific Antibody Fusion ProteinBiological
A recombinant PD-1/IL-2 bispecific antibody fusion protein that simultaneously blocks the PD-1/PD-L1 pathway and activates the IL-2 signaling pathway. It is administered by intravenous infusion as neoadjuvant therapy prior to curative surgical resection. Patients receive multiple cycles of treatment, starting with a lower priming dose followed by standard doses administered every 2 weeks. After completing neoadjuvant treatment, eligible patients proceed to curative hepatectomy followed by long-term follow-up.
| Study group | Role | What they receive |
|---|---|---|
| PD-1/IL-2 Bispecific Antibody Fusion Protein Neoadjuvant Therapy | Experimental | Patients will receive neoadjuvant treatment with a PD-1/IL-2 Bispecific Antibody Fusion Protein administered by intravenous infusion for 3 cycles prior to surgery. Patients who remain eligible after completing neoadjuvant treatment will undergo curative surgical resection, followed by pathological response assessment and long-term follow-up for survival and disease recurrence. Receives: Biological: PD-1/IL-2 Bispecific Antibody Fusion Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response Rate (MPR)
Major Pathological Response (MPR) is defined as the proportion of patients with ≤50% residual viable tumor cells in the resected specimen after neoadjuvant treatment,
Measured: 24 months
Secondary outcomes (7)
Complete Pathological Response Rate (pCR)
Defined as the proportion of patients with no residual viable tumor cells found in the completely resected surgical specimen after neoadjuvant treatment,
Measured: 24 months
Event-Free Survival (EFS)
Defined as the time from the first dose to the first occurrence of disease progression that prevents curative resection, post-operative local recurrence, distant metastasis, or death from any cause, whichever occurs first.
Measured: From first dose to up to 2 years after surgery
Overall Survival (OS)
Defined as the time from the first dose to death from any cause.
Measured: From first dose to up to 5 years after surgery
R0 Resection Rate
Defined as the proportion of patients achieving complete surgical resection with no residual microscopic tumor at the resection margins,
Measured: At the time of surgical resection, approximately 7-11 weeks after the first dose of neoadjuvant treatment
Objective Response Rate (ORR)
Defined as the proportion of patients achieving complete response (CR) or partial response (PR) per RECIST v1.1 criteria, as assessed by local investigators.
Measured: From first dose to pre-surgical tumor assessment, approximately 7-11 weeks after the first dose of neoadjuvant treatment
Disease Control Rate (DCR)
Defined as the proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1 criteria, as assessed by local investigators.
Measured: From first dose to pre-surgical tumor assessment, approximately 7-11 weeks after the first dose of neoadjuvant treatment
Incidence of Adverse Events (Safety)
Incidence, severity, and relationship to study drug of all adverse events (AEs),
Measured: From first dose to 90 days after the last dose of neoadjuvant treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhou, Shanghai Zhongshan Hospital
- Investigators
- Jian Zhou, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644208
- Sponsor's protocol ID
- NEOHCC-BSP
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 12 Jun 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Efficacy and Safety of PD-1/IL-2 Bispecific Antibody as Neoadjuvant Therapy in Hepatocellular Carcinoma Patients With Early Recurrence After Curative Hepatectomy and Eligible for Re-resection
- ClinicalTrials.gov ID
- NCT07644208
- Acronym / sponsor ID
- NEOHCC-BSP
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- Hepatocellular Carcinoma, Neoadjuvant Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 12 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.
This is a single-arm, phase II clinical study designed to evaluate the efficacy and safety of a recombinant PD-1/IL-2 bispecific antibody, as neoadjuvant therapy in hepatocellular carcinoma (HCC) patients who experienced early recurrence after curative hepatectomy and were suitable for repeat surgical resection.
A total of approximately 30 eligible participants are planned to be enrolled. All patients will receive neoadjuvant treatment with PD-1/IL-2 bispecific antibody for 3 cycles. Curative re-resection will be performed 2 to 7 weeks after the last dose of PD-1/IL-2 bispecific antibody for patients with resectable lesions confirmed by imaging assessment. Tumor evaluation will be conducted per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) throughout the study. Postoperative pathological assessment and long-term follow-up will be implemented after surgery.
The primary endpoint is the major pathological response (MPR) rate. Secondary endpoints include complete pathological response (pCR) rate, event-free survival (EFS), overall survival (OS), R0 resection rate, objective response rate (ORR), disease control rate (DCR), and the safety and tolerability profile . Exploratory endpoints aim to analyze the correlation between biomarkers (e.g., PD-L1 expression, tumor microenvironment) and treatment efficacy.
This study intends to explore the clinical value of PD-1/IL-2 bispecific antibody in the neoadjuvant setting for recurrent resectable HCC, and provide evidence for its clinical application in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-1/IL-2 Bispecific Antibody Fusion Protein Neoadjuvant Therapy | Experimental | Biological: PD-1/IL-2 Bispecific Antibody Fusion ProteinPatients will receive neoadjuvant treatment with a PD-1/IL-2 Bispecific Antibody Fusion Protein administered by intravenous infusion for 3 cycles prior to surgery. Patients who remain eligible after completing neoadjuvant treatment will undergo curative surgical resection, followed by pathological response assessment and long-term follow-up for survival and disease recurrence. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Have signed the written informed consent form and be able to comply with all scheduled visits and study procedures specified in the protocol.
- Aged between 18 and 75 years old (inclusive), with no restriction on gender.
- Diagnosed with hepatocellular carcinoma (HCC) confirmed by histopathology or cytology, or meeting the clinical diagnostic criteria for HCC formulated by the American Association for the Study of Liver Diseases (AASLD) or the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer.
- Must provide tumor tissue specimens obtained from the initial surgical resection during the screening period.
- Have a history of curative hepatectomy for HCC, with pathologically confirmed tumor recurrence occurring 3 months to 2 years after surgery. Candidates shall be assessed by a multidisciplinary team (MDT) and meet all the following criteria for repeat resection:
Key exclusion criteria (36 listed)
- Histologically or cytologically confirmed diagnosis of tumors containing components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, mixed carcinoma, and intrahepatic cholangiocarcinoma.
- Prior treatment with anti-PD-1/PD-L1 agents or other antitumor immunotherapies.
- Presence of unresolved Grade >1 toxicities related to any previous antitumor therapy (persistent Grade 2 alopecia, anemia, peripheral neuropathy, electrolyte abnormalities manageable with treatment, and endocrine disorders well-controlled with hormone replacement therapy are excluded).
- History of hepatic encephalopathy or seizures; presence of active, newly diagnosed or untreated central nervous system metastases, spinal cord compression, carcinomatous meningitis or leptomeningeal metastases.
- Presence of clinically significant cardiovascular and cerebrovascular diseases, including:
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 |
|---|---|---|
| PD-1/IL-2 Bispecific Antibody Fusion ProteinA recombinant PD-1/IL-2 bispecific antibody fusion protein that simultaneously blocks the PD-1/PD-L1 pathway and activates the IL-2 signaling pathway. It is administered by intravenous infusion as neoadjuvant therapy prior to curative surgical resection. Patients receive multiple cycles of treatment, starting with a lower priming dose followed by standard doses administered every 2 weeks. After completing neoadjuvant treatment, eligible patients proceed to curative hepatectomy followed by long-term follow-up. | Biological | PD-1/IL-2 Bispecific Antibody Fusion Protein Neoadjuvant Therapy |
Primary outcome
Major Pathological Response Rate (MPR)
Time frame: 24 months
Major Pathological Response (MPR) is defined as the proportion of patients with ≤50% residual viable tumor cells in the resected specimen after neoadjuvant treatment,
7 secondary outcomes
Complete Pathological Response Rate (pCR)
Time frame: 24 months
Event-Free Survival (EFS)
Time frame: From first dose to up to 2 years after surgery
Overall Survival (OS)
Time frame: From first dose to up to 5 years after surgery
R0 Resection Rate
Time frame: At the time of surgical resection, approximately 7-11 weeks after the first dose of neoadjuvant treatment
Objective Response Rate (ORR)
Time frame: From first dose to pre-surgical tumor assessment, approximately 7-11 weeks after the first dose of neoadjuvant treatment
Disease Control Rate (DCR)
Time frame: From first dose to pre-surgical tumor assessment, approximately 7-11 weeks after the first dose of neoadjuvant treatment
Incidence of Adverse Events (Safety)
Time frame: From first dose to 90 days after the last dose of neoadjuvant treatment
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 12 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.
Jian Zhou principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PD-1/IL-2 Bispecific Antibody Fusion Protein in people with Hepatocellular Carcinoma (HCC), run by Shanghai Zhongshan Hospital.
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 15 inclusion and 36 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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 XiaoYong Huang (+8615021519215, huang.xiaoyong@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response Rate (MPR) (time frame: 24 months). 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 12 Jun 2026.