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Hepatocellular CarcinomaPhase 2NCT07324824

Sintilimab Plus Bevacizumab Biosimilar as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma

A Phase 2 study testing sintilimab combined with bevacizumab biosimilar in people with Hepatocellular Carcinoma and Neoadjuvant Therapy, run by Sun Yat-sen University 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
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Trial summary

Surgical resection is the preferred therapeutic modality for patients with resectable hepatocellular carcinoma (HCC). However, the recurrence rate of HCC remains up to 70%. Neoadjuvant therapy for HCC could potentially reduce the risk of postoperative recurrence and prolong overall survival. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
sintilimab combined with bevacizumab biosimilar
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteChina
Study dates
14 Jan 2026to Jan 2030
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

  • Able to provide informed consent and willing to sign an approved consent form;
  • Aged ≥ 18 years;
  • Clinically diagnosed or pathologically confirmed resectable hepatocellular carcinoma beyond the Milan criteria (CNLC Ib-IIa);
  • No prior anti-HCC treatment;
  • Child-Pugh class A.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
  • Expected survival time of > 6 months.
  • Sufficient organ and bone marrow function.

Who cannot join

  • Known as cholangiocarcinoma (ICC) or mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and hepatic fibrolamellar carcinoma;
  • History of organ transplantation or hepatic encephalopathy
  • Pleural fluid, ascites, and pericardial effusion with clinical symptoms requiring drainage
  • History of esophageal or gastric variceal bleeding caused by portal hypertension within the past 6 months; Documented severe (Grade 3) varices identified by endoscopy within 3 months prior to enrollment; Evidence of portal hypertension and assessed by the investigator as being at high risk of bleeding.
  • Arterial and venous thromboembolic events in the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis or any other serious thromboembolism history;
  • Any life-threatening bleeding event occurring within the past 3 months;
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  • Severe bleeding tendency, coagulopathy, or ongoing thrombolytic therapy.
  • Chronic requirement for medications that inhibit platelet function, such as aspirin (>325 mg/day), dipyridamole, or clopidogrel.
  • Uncontrolled hypertension, defined as systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg despite optimal medical management; history of hypertensive crisis or hypertensive encephalopathy.
  • Symptomatic congestive heart failure (New York Heart Association [NYHA] Functional Class II-IV); symptomatic or poorly controlled arrhythmias; history of congenital long QT syndrome; or corrected QT interval (QTc) >500 ms at screening (calculated using Fridericia's formula).
  • History of gastrointestinal perforation and/or fistula, intestinal obstruction (including incomplete obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic persistent diarrhea within the past 6 months.
  • Major surgical procedure (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to enrollment; presence of unhealed wounds, ulcers, or fractures; or tissue biopsy or other minor surgical procedure within 7 days prior to enrollment, excluding venous catheterization for intravenous infusion.
  • Past or current history of pulmonary diseases including pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-induced pneumonia, or severe impairment of lung function.
  • Active acute or chronic hepatitis B or C infection, defined as: hepatitis B virus (HBV) DNA >2000 IU/mL or 10⁴ copies/mL; hepatitis C virus (HCV) RNA >10³ copies/mL; or concurrent positivity for hepatitis B surface antigen (HBsAg) and anti-HCV antibodies.
  • Active tuberculosis (TB); ongoing anti-TB treatment; or anti-TB treatment completed within 1 year prior to the initiation of study treatment.
  • Human immunodeficiency virus (HIV) infection (positive for HIV 1/2 antibodies); known syphilis infection.
  • Severe active infection or infection with poor clinical control.
  • Active autoimmune disease requiring systemic therapy (e.g., disease-modifying antirheumatic drugs, corticosteroids, or immunosuppressants) within 2 years prior to enrollment. Substitution therapy (e.g., thyroid hormone, insulin, or physiological doses of corticosteroids for adrenal or pituitary insufficiency) is permitted. A history of known primary immunodeficiency is excluded. Patients with isolated positive autoimmune antibodies must be evaluated by the investigator to confirm the absence of underlying autoimmune disease.
  • Use of immunosuppressive drugs within 4 weeks prior to enrollment, excluding intranasal, inhaled, or other topical corticosteroids, or systemic corticosteroids at physiological doses (i.e., ≤10 mg/day of prednisone or equivalent). Temporary use of corticosteroids for the management of dyspnea related to asthma, chronic obstructive pulmonary disease (COPD), or other conditions is permitted.
  • Administration of live-attenuated vaccines within 4 weeks prior to enrollment or planned administration of live-attenuated vaccines during the study period.
  • Use of immunomodulatory agents (including thymosin, interferons, or interleukins) within 2 weeks prior to enrollment, excluding local administration for the control of pleural effusion or ascites.
  • Uncontrolled/uncorrectable metabolic disorders, other non-malignant organ/systemic diseases, or cancer-related sequelae that pose a high medical risk and/or introduce uncertainty in survival assessment.
  • Diagnosis of other malignant tumors within 5 years prior to enrollment, excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected carcinoma in situ. For malignant tumors diagnosed more than 5 years prior to drug administration, pathological or cytological confirmation of recurrent or metastatic lesions is required.
  • Prior receipt of any anti-angiogenic agents, anti-PD-1 antibodies, anti-PD-L1/L2 antibodies, anti-CTLA-4 antibodies, or other immunotherapies.
  • Known hypersensitivity to sintilimab, bevacizumab formulations, or their excipients; or history of severe hypersensitivity reactions to other monoclonal antibodies.
  • Receipt of treatment in other clinical trials within 4 weeks prior to enrollment.
  • Pregnant or breastfeeding female patients.
  • Other acute or chronic diseases, psychiatric disorders, or abnormal laboratory findings that, in the investigator's judgment, would: increase the risk associated with study participation or study drug administration; interfere with the interpretation of study results; or render the patient ineligible for study participation.

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

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Zhongguo Zhou, +8602087343115, zhouzhg@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: Sintilimab Combined With Bevacizumab as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma Beyond the Milan Criteria: A Single-Arm, Prospective Phase II Study

Surgical resection is the preferred therapeutic modality for patients with resectable hepatocellular carcinoma (HCC). However, the recurrence rate of HCC remains up to 70%. Neoadjuvant therapy for HCC could potentially reduce the risk of postoperative recurrence and prolong overall survival. Nevertheless, there is no standard neoadjuvant treatment regimen for HCC to date. In recent years, targeted therapy and immunotherapy are proved to improve the prognosis of advanced HCC patients. Previous study (ORIENT-32) has confirmed that, compared with sorafenib, sintilimab combined with bevacizumab biosimilar can delay tumor progression, reduce the risk of death, and exhibit a favorable safety profile in patients with advanced HCC. Therefore, we conducted a prospective, single-arm phase II study to investigate the efficacy of sintilimab combined with a bevacizumab biosimilar as neoadjuvant therapy in patients with resectable HCC beyond the Milan criteria.

Being tested
sintilimab combined with bevacizumab biosimilar
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • sintilimab combined with bevacizumab biosimilarDrug

    Drug: Sintilimab: 200mg IV Q3W D1 (3 cycles) Drug: Bevacizumab Biosimilar: 15mg/kg, IV, Q3W, D1 (2 cycles)

Study groups in NCT07324824
Study groupRoleWhat they receive
sintilimab combined with bevacizumab biosimilarExperimentalNot described
Receives: Drug: sintilimab combined with bevacizumab biosimilar

What is being measured

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

  1. 1-year recurrence free survival rate

    Defined as the proportion of patients who remain free from any tumor recurrence or death within 1 year after liver resection.

    Measured: Up to 2 years

  2. Adverse Events (AEs)

    Defined as the proportion of patients with AEs assessed by NCI CTCAE v5.0;

    Measured: Up to 2 years

Secondary outcomes (6)

  1. R0 resection rate

    Defined as the proportion of patients received R0 resection

    Measured: Up to 2 years

  2. pathological complete response

    Defined as the proportion of patients who had pathological complete response

    Measured: Up to 2 years

  3. major pathological response

    Defined as the proportion of patients who had major pathological response

    Measured: Up to 2 years

  4. Overall survival

    Defined as the interval from the date of enrollment to the date of death or to the date of last follow-up (whichever occurs first)

    Measured: Up to 2 years

  5. Recurrence free survival

    Defined as the time from the date of liver resection to the date of recurrence or death (whichever occurs first)

    Measured: Up to 2 years

  6. Time to recurrence

    Defined as the time from the date of liver resection to the date of tumor recurrence

    Measured: Up to 2 years

Timeline

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

  1. First posted8 Jan 2026
  2. Study start14 Jan 2026
  3. Primary completionJan 2029 (estimated)
  4. Study completionJan 2030 (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
37 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07324824
Sponsor's protocol ID
B2024-720-01
Status last verified
Jan 2026
First submitted
23 Dec 2025
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sintilimab combined with bevacizumab biosimilar in people with Hepatocellular Carcinoma and Neoadjuvant Therapy, 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 8 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: looking for participants now, as of the sponsor's last update on 16 Jan 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year recurrence free survival rate (time frame: Up to 2 years). 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?

On the ClinicalTrials.gov record for NCT07324824.

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 16 Jan 2026.

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