Sintilimab Combined With Stereotactic Body Radiotherapy as Neoadjuvant Therapy for Resectable Hep… (NCT07352007) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Sintilimab Combined With Stereotactic Body Radiotherapy as Neoadjuvant Therapy for Resectable Hepatocellular
China110 participantsStarted 2025-12-28
Plain-language 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.
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Child-Pugh score of ≤7.
✓. No prior systemic antitumor therapy for hepatocellular carcinoma.
Exclusion criteria
✕. History of any histologically/cytologically confirmed malignancy other than HCC.
✕. History of hepatic encephalopathy, or history of liver transplantation.
What they're measuring
1
Three-year recurrence rate
Timeframe: From date of resection until the date of first documented progression, assessed up to 3 years
. 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.
✕. 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.