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

NCT07352007 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-01-20

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

SBRT

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

DRUG

Sintilimab

200mg ivgtt,D1,Q3W

PROCEDURE

Surgery

Surgery

Sponsors & Collaborators

  • Lei ZHAO

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-28
Primary Completion
2028-01-20
Completion
2031-01-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07352007 on ClinicalTrials.gov