NCT06664996

Sintilimab Combined SBRT As Neoadjuvant Therapy for Resectable HCC with PVTT

Sintilimab Combined with Stereotactic Body Radiation Therapy As Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma with Branch Portal Vein Tumor Thrombus: a Single-arm, Prospective Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this single-arm, prospective clinical trial is to evaluate the safety and efficacy of neoadjuvant therapy combining sintilimab with stereotactic body radiation therapy (SBRT) in patients with resectable hepatocellular carcinoma (HCC) with branch portal vein tumor thrombus. The main questions it aims to answer are: 1. Is the combination of sintilimab and SBRT safe as neoadjuvant therapy? 2. How effective is this combination in treating resectable HCC with branch PVTT? Participants will be given a combination treatment of sintilimab and SBRT. Researchers will monitor their health conditions to assess the safety and effectiveness of this treatment protocol.

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
RADIATION	stereotactic body radiation therapy (SBRT)	SBRT will be administered on days 1, 3, and 5 at a dose of 8 Gy per fraction, totaling 3 fractions.
DRUG	Sintilimab (approved)	patients will receive a first dose of sintilimab at 200 mg on day 1, followed by a second dose of 200 mg on day 22 (week 4, ±3 days).

Timeline

• Start date: 2024-10-15
• Primary completion: 2025-10-01
• Completion: 2026-10-01
• First posted: 2024-10-30
• Last updated: 2024-10-30

Locations

1 site across 1 country: China