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Sintilimab Combined SBRT As Neoadjuvant Therapy for Resectable HCC with PVTT

NCT06664996 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2024-10-30

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-15
Primary Completion
2025-10-31
Completion
2026-10-31

Countries

  • China

Study Locations

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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 NCT06664996 on ClinicalTrials.gov