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HCCPhase 2NCT07352007

Sintilimab Combined With Stereotactic Body Radiotherapy as Neoadjuvant Therapy for Resectable Hepatocellular

A Phase 2 study testing SBRT, Sintilimab and Surgery in people with HCC, run by Lei ZHAO at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is a prospective, randomized controlled, phase II trial evaluating the efficacy and safety of neoadjuvant therapy with Sintilimab combined with SBRT in patients with resectable hepatocellular carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
HCC
What is being tested?
SBRT, Sintilimab and Surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteChina
Study dates
28 Dec 2025to 20 Jan 2031
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 provided and signed prior to the implementation of any trial-related procedures.
  • Male or female subjects aged ≥18 years and ≤75 years.
  • ECOG PS score of 0-1.
  • BCLC 0-B.
  • Diagnosed with HCC according to the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2019 Edition).
  • CNLC Stage IA-IIB.
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  • Child-Pugh score of ≤7.
  • No prior systemic antitumor therapy for hepatocellular carcinoma.
  • Assessed as suitable for R0 resection surgery.
  • Assessed as having no contraindications to SBRT and immunotherapy.
  • Estimated life expectancy of >3 months.
  • At least one measurable lesion according to RECIST 1.1 or mRECIST criteria.
  • Adequate organ and bone marrow function, defined as follows:a) Hematology: Absolute neutrophil count (ANC) ≥1.5×10⁹/L; Platelet count (PLT) ≥75×10⁹/L; Hemoglobin (HGB) ≥9.0 g/dL.b) Liver function: Serum total bilirubin (TBIL) ≤3 × upper limit of normal (ULN); Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤5 × ULN; Serum albumin ≥28 g/L.c) Renal function: Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 50 mL/min (Cockcroft-Gault formula); Urinalysis shows urine protein <2+; For patients with baseline urinalysis showing urine protein ≥2+, a 24-hour urine collection must demonstrate 24-hour urine protein <1 g.d) Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
  • For subjects with acute or chronic active hepatitis B or C infection, continuous antiviral therapy must be administered during the study period.
  • For female subjects of childbearing potential, a negative urine or serum pregnancy test must be confirmed within 3 days prior to receiving the first dose of the study drug (Cycle 1, Day 1). If a urine pregnancy test is inconclusive, a blood pregnancy test is required. Non-childbearing potential is defined as being post-menopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy.
  • If there is a risk of conception, all subjects (both male and female) must use highly effective contraceptive methods (with a failure rate of <1% per year) throughout the entire treatment period and for at least 120 days after the last dose of the study drug (or 180 days after the last dose of chemotherapy). Estimated life expectancy ≥12 weeks.

Who cannot join

  • History of any histologically/cytologically confirmed malignancy other than HCC.
  • History of hepatic encephalopathy, or history of liver transplantation.
  • Presence of any extrahepatic metastatic lesions.
  • Prior receipt of any systemic antitumor therapy for HCC, including treatment with antibodies such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 agents.
  • Acute or chronic active 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; Co-positive for Hepatitis B surface antigen (HBsAg) and anti-HCV antibody.
  • Radiotherapy received within 3 weeks prior to the first dose.
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  • Human Immunodeficiency Virus (HIV) infection (positive HIV 1/2 antibodies) or known active syphilis infection.
  • Severe infections that are either active or poorly controlled clinically.
  • Active autoimmune disease that required systemic treatment within the past 2 years prior to the first dose.
  • Known history of primary immunodeficiency. The presence of autoimmune antibodies alone requires the investigator's judgment to confirm the presence of an autoimmune disease.
  • Use of immunosuppressive medication within 4 weeks prior to the first dose, with the exception of intranasal, inhaled, or other routes of locally administered corticosteroids, or systemic corticosteroids at physiological doses (i.e., not exceeding 10 mg/day prednisone or an equivalent dose of other corticosteroids). Temporary use of corticosteroids for conditions such as asthma or COPD for dyspnea is permitted.
  • Administration of any live attenuated vaccine within 4 weeks prior to the first dose or planned administration during the study period.
  • Any local therapy for liver cancer received within 4 weeks prior to the first dose.
  • Diagnosis of another malignancy within 5 years prior to the first dose, with the exception of radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has undergone radical resection. If another malignancy or HCC was diagnosed more than 5 years prior to the first dose, pathological or cytological confirmation is required for any recurrent or metastatic lesions.
  • Known allergy to any component of the Sintilimab formulation; or history of severe allergic reactions to other monoclonal antibodies or tyrosine kinase inhibitors.
  • Treatment received as part of another clinical trial within 4 weeks prior to the first dose.
  • Female patients who are pregnant or breastfeeding.
  • Any other acute or chronic disease, psychiatric disorder, or abnormal laboratory test value that may lead to the following outcomes: increased risk associated with study participation or study drug administration, interference with the interpretation of study results, and based on the investigator's judgment, makes the patient unsuitable 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.

China1 site

  • ShandongShandong Cancer Hospital and Institute

    Jinan, Shandong

Other trials in China

About this study

Official title: A Prospective, Randomized Controlled, Phase II Study of Sintilimab Combined With Stereotactic Body Radiotherapy as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma

This study is a prospective, randomized controlled, phase II trial evaluating the efficacy and safety of neoadjuvant therapy with Sintilimab combined with SBRT in patients with resectable hepatocellular carcinoma.

After meeting the inclusion and exclusion criteria and providing informed consent, eligible subjects will be randomly assigned to the experimental group or the control group:

  • Experimental Group: Subjects will receive Sintilimab 200 mg via intravenous infusion on day 1 of each 3-week cycle, for a total of two cycles. This will be combined with SBRT, administered as 8 Gy per fraction for 3 fractions on days 1, 3, and 5. Surgery will be performed 4-6 weeks after the last treatment, following the assessment of the patient's condition. Postoperative adjuvant therapy with Sintilimab monotherapy (200 mg Q3W) will be administered until disease recurrence, death, intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, or other protocol-specified reasons occur, for a maximum of one year.
  • Control Group:Subjects will undergo surgery directly. Postoperative adjuvant therapy with Sintilimab monotherapy (200 mg Q3W) will be administered until disease recurrence, death, intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, or other protocol-specified reasons occur, for a maximum of one year.
Conditions
HCC
Being tested
SBRT, Sintilimab, Surgery

What participants receive

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

  • SBRTProcedure or surgery

    SBRT :8 Gy per fraction for 3 fractions on days 1, 3, and 5.

  • SintilimabDrug

    200mg ivgtt,D1,Q3W

  • SurgeryProcedure or surgery

    Surgery

Study groups in NCT07352007
Study groupRoleWhat they receive
Sintilimab +Stereotactic Body Radiotherapy +surgeryExperimentalSintilimab 200 mg via intravenous infusion on day 1 of each 3-week cycle, for a total of two cycles. This will be combined with SBRT, administered as 8 Gy per fraction for 3 fractions on days 1, 3, and 5. Surgery will be performed 4-6 weeks after the last treatment, following the assessment of the patient's condition.
Receives: Procedure: SBRT; Drug: Sintilimab; Procedure: Surgery
controlOtherSurgery
Receives: Procedure: Surgery

What is being measured

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

  1. Three-year recurrence rate

    the proportion of individuals who experience their first radiological recurrence or death (whichever occurs first) from the time of enrollment in the group until the 3-year time point.

    Measured: From date of resection until the date of first documented progression, assessed up to 3 years

Secondary outcomes (4)

  1. Five-year recurrence rate

    the proportion of individuals who experience their first radiological recurrence or death (whichever occurs first) from the time of enrollment in the group until the 5-year time point.

    Measured: From date of resection until the date of first documented progression, assessed up to 5 years

  2. Recurrence free survival

    the time from the end of treatment to tumor recurrence or patient death.

    Measured: From date of resection until the date of first documented progression, assessed up to 3 years

  3. Overall survival (OS)

    as the time from enrollment to the death of the subject for any reason

    Measured: From date of resection until the date of death from any cause, assessed up to 5 years

  4. Pathologic complete response (pCR)

    The proportion of subjects whose postoperative pathological examination did not detect residual cancer cells

    Measured: Up to one year

Timeline

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

  1. First posted20 Jan 2026
  2. Study start28 Dec 2025 (estimated)
  3. Primary completion20 Jan 2028 (estimated)
  4. Study completion20 Jan 2031 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07352007
Sponsor's protocol ID
Notable-HCC-II
Status last verified
Jan 2026
First submitted
11 Jan 2026
Last updated
20 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SBRT, Sintilimab and Surgery in people with HCC, run by Lei ZHAO 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 16 inclusion and 18 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 20 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Three-year recurrence rate (time frame: From date of resection until the date of first documented progression, assessed up to 3 years). 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 NCT07352007.

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 20 Jan 2026.

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