About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- SBRT
- Sintilimab
- Surgery
Treatment groups
Sponsors and collaborators
Lei ZHAO
Lead sponsor
Shandong Cancer Hospital and Institute
Sponsor institution