AzTrials
AzTrials

HCC - Hepatocellular CarcinomaPhase 2NCT07560488

Ipilimumab N01 Combined With Sintilimab, Bevacizumab Biosimilar, and Hepatic Arterial Infusion Chemotherapy as Conversion Therapy for Unresectable Intermediate-Advanced Hepatocellular Carcinoma

A Phase 2 study testing Bevacizumab Biosimilar IBI305, ipilimumab N01 and Sintilimab in people with HCC - Hepatocellular Carcinoma and Conversion Therapy, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Conversion therapy for unresectable intermediate-advanced hepatocellular carcinoma (uHCC) has evolved from systemic therapy to combined local-systemic approaches, but current regimens still have limited surgical conversion rates. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Bevacizumab Biosimilar IBI305, ipilimumab N01 and Sintilimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteChina
Study dates
30 Mar 2026to Apr 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent must be signed prior to initiation of any study-related procedures;
  • Age ≥ 18 years, and ≤75 years, regardless of gender;
  • Clinically diagnosed or histologically/cytologically confirmed hepatocellular carcinoma (HCC) according to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition);
  • No prior anti-tumor therapy for HCC before study treatment
  • Unresectable locally advanced or advanced HCC (CNLC Stage IIa-IIIb).
  • Expected overall survival > 6 months.
Show all 20Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Child-Pugh score class A or B
  • Adequate organ function defined by the following laboratory parameters:
  • Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L without granulocyte colony-stimulating factor support within 14 days;
  • Platelet count ≥ 80×10⁹/L without transfusion within 14 days;
  • Hemoglobin > 9 g/dL without transfusion or erythropoietin within 14 days;
  • Total bilirubin ≤ 1.5×upper limit of normal (ULN); or total bilirubin > ULN with direct bilirubin ≤ ULN;
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3×ULN;
  • Serum creatinine ≤ 1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥ 60 mL/min;
  • Adequate coagulation function defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5×ULN;
  • Normal thyroid function defined as thyroid-stimulating hormone (TSH) within normal limits. Subjects with abnormal baseline TSH but normal total T3 (or FT3) and FT4 are also eligible;
  • Myocardial enzymes within normal limits; isolated laboratory abnormalities deemed clinically insignificant by the investigator are permitted.
  • Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days before the first dose of study drug (Day 1 of Cycle 1). A blood pregnancy test is required if the urine test is inconclusive; They must agree to use adequate contraception during the study period and for 8 weeks after the last dose of study drug;
  • All subjects (male or female) of reproductive potential must use a highly effective contraceptive method with an annual failure rate < 1% throughout treatment and for 120 days after the last dose of immunotherapy or 180 days after the last dose of chemotherapy, whichever is longer.

Who cannot join

  • Target disease exceptions:
  • Fibrolamellar HCC, sarcomatoid HCC, or combined hepatocellular-cholangiocarcinoma.
  • Recurrent HCC.
  • Clinically diagnosed hepatic encephalopathy within the most recent 6 months.
  • Autoimmune hepatitis (requiring liver biopsy confirmation);
  • History of organ transplantation or history of hepatic encephalopathy;
Show all 34Show fewer
  • Diffuse hepatocellular carcinoma;
  • Symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage;
  • History of any renal disease or nephrotic syndrome.
  • Variceal bleeding (esophageal or gastric varices) due to portal hypertension within the past 6 months;severe (Grade 3) varices on endoscopy within 3 months before first dose;evidence of portal hypertension (e.g., splenomegaly >10 cm in longest diameter with platelets <100×10⁹/L on imaging) with high bleeding risk as assessed by the investigator;
  • Arterial or venous thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other severe thromboembolism.Excluded are catheter-related or port-related thrombosis or superficial venous thrombosis that is stable with standard anticoagulation;
  • Severe bleeding tendency or coagulopathy, or ongoing thrombolytic therapy;
  • Prophylactic low-molecular-weight heparin (e.g., enoxaparin 40 mg daily) is permitted; vitamin K antagonists (e.g., warfarin) are excluded;
  • Long-term use of anti-platelet agents including aspirin, dipyridamole, clopidogrel, or other similar medications;
  • Uncontrolled hypertension despite optimal medical management (systolic BP >140 mmHg or diastolic BP >90 mmHg); history of hypertensive crisis or hypertensive encephalopathy;
  • Symptomatic congestive heart failure (NYHA Class II-IV); symptomatic or poorly controlled arrhythmia; congenital long QT syndrome or QTcF >500 ms at screening;
  • History of gastrointestinal perforation and/or fistula within the past 6 months; history of bowel obstruction (including partial obstruction requiring parenteral nutrition); extensive bowel resection, Crohn's disease, ulcerative colitis, or chronic diarrhea;
  • Major surgical procedure (cranial, thoracic, or abdominal) within 4 weeks before first dose, or non-healing wounds, ulcers, or fractures.Core needle biopsy or minor surgery within 7 days before first dose is excluded, except for venous catheter placement for intravenous access;
  • History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-induced pneumonitis, or severe pulmonary dysfunction;
  • Acute or chronic active hepatitis B or C infection:HBV DNA >2000 IU/mL or 10⁴ copies/mL;HCV RNA >10³ copies/mL;coinfection with HBsAg and anti-HCV antibody;
  • Active tuberculosis (TB), ongoing anti-TB treatment, or anti-TB treatment within 1 year before first dose;
  • Human immunodeficiency virus (HIV) infection (positive HIV 1/2 antibody) or active syphilis;
  • Active or poorly controlled severe infection; severe infection requiring hospitalization (including sepsis, bacteremia, or severe pneumonia) within 4 weeks before first dose;
  • Active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years before first dose.Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal/pituitary insufficiency) is permitted.History of primary immunodeficiency.Subjects with isolated positive autoimmune antibodies will be evaluated at the investigator's discretion;
  • Systemic immunosuppressive drugs within 4 weeks before first dose, excluding topical, inhaled, or intranasal corticosteroids or physiological systemic corticosteroids (≤10 mg/day prednisone or equivalent).Temporary corticosteroids for acute dyspnea in asthma or COPD are permitted;
  • Live attenuated vaccine within 4 weeks before first dose or planned use during the study period;
  • Chinese herbal medicine with anti-tumor indications, or immunomodulatory agents (including thymosin, interferon, interleukin) within 2 weeks before first dose, except for local administration for pleural effusion or ascites;
  • Uncontrolled or irreversible metabolic disorders, other acute or chronic non-malignant organ diseases, systemic illnesses, or paraneoplastic syndromes that may increase medical risk or confound survival assessment;
  • Diagnosis of another malignancy within 5 years before first dose, except for radically treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ.For other malignancies diagnosed >5 years before enrollment, pathological or cytological confirmation of recurrent/metastatic lesions is required;
  • Prior treatment with anti-PD-1, anti-PD-L1/L2, anti-CTLA-4 antibodies, or other immune checkpoint inhibitors;
  • Known hypersensitivity to sintilimab, bevacizumab, ipilimumab N01 or their excipients, or severe hypersensitivity to other monoclonal antibodies;
  • Participation in another interventional clinical trial within 4 weeks before first dose;
  • Female subjects who are pregnant or breastfeeding;
  • Any other acute or chronic diseases, psychiatric disorders, or abnormal laboratory values that may increase risks associated with study participation or study drug administration, or interfere with the interpretation of study results, and that, in the investigator's judgment, render the patient ineligible for participation in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Huikai Li, Prof. contact

+8618526812877

18526812877@163.com

China1 site, 1 recruiting

  • Tianjin Cancer Hospital Airport Hospital

    Tianjin, Tianjin Municipality

    Huikai Li, Prof., 18622228639, tjchlhk@126.com

    Recruiting

Other trials in China

About this study

Official title: Conversion Therapy With Ipilimumab N01 Combined With Sintilimab, Bevacizumab Biosimilar, and Hepatic Arterial Infusion Chemotherapy for Unresectable Intermediate-Advanced Hepatocellular Carcinoma: A Prospective, Single-Arm Phase II Study

Conversion therapy for unresectable intermediate-advanced hepatocellular carcinoma (uHCC) has evolved from systemic therapy to combined local-systemic approaches, but current regimens still have limited surgical conversion rates.

This prospective, single-arm phase II study evaluates a combination regimen of PD-1 inhibitor (sintilimab) plus CTLA-4 inhibitor (ipilimumab N01), bevacizumab biosimilar, and HAIC for patients with initially unresectable intermediate-advanced HCC. The primary goal is to achieve a higher surgical conversion rate with manageable safety

Being tested
Bevacizumab Biosimilar IBI305, ipilimumab N01, Sintilimab, HAIC
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bevacizumab Biosimilar IBI305Drug

    7.5 mg/kg, iv, q3w, 3 cycles (discontinue 1 week before surgery)

  • ipilimumab N01Drug

    3mg/kg, iv, q6w, 2 cycles

  • SintilimabDrug

    200mg, iv, q3w, 4 cycles

  • HAICDrug

    FOLFOX-HAIC, q3w, 4 cycles

Study groups in NCT07560488
Study groupRoleWhat they receive
Ipilimumab N01+Sintimab+Bevacizumab+HAICExperimentalNot described
Receives: Drug: Bevacizumab Biosimilar IBI305; Drug: ipilimumab N01; Drug: Sintilimab; Drug: HAIC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Conversion resection rate

    The percentage of initially unresectable patients who underwent curative resection after protocol-specified conversion therapy.

    Measured: up to 1 year

Secondary outcomes (5)

  1. Objective response rate

    the percentage of participants in the analysis population who had a CR(Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) usingRECIST1.1 based oninvestiqator assessment

    Measured: up to 1 year

  2. R0 Resection Rate

    Proportion of patients achieving complete tumor resection with microscopically negative margins after successful conversion therapy

    Measured: up to 1 year

  3. Pathological Complete Response

    The proportion of patients in whom no residual viable tumor cells are detected upon histopathological examination of the surgically resected specimen.

    Measured: up to 1 year

  4. Overall survival

    OS was defined as the time from the first dose of study drug to death due to anycause.

    Measured: up to 3 years

  5. Treatment-Related Adverse Events (TRAE)

    Treatment-Related Adverse Events (TRAE) as assessed by CTCAE v5.0, including serious adverse events (SAE)

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2026
  2. Study start30 Mar 2026
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

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
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07560488
Sponsor's protocol ID
SIBH-HCC
Status last verified
Apr 2026
First submitted
1 Apr 2026
Last updated
1 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab Biosimilar IBI305, ipilimumab N01 and Sintilimab in people with HCC - Hepatocellular Carcinoma and Conversion Therapy, 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 20 inclusion and 34 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 1 May 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?

Contact Huikai Li, Prof. (+8618526812877, 18526812877@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Conversion resection rate (time frame: up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07560488.

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 1 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in