RecruitingPhase 2NCT06397222

Sintilimab Plus Bevacizumab and SIRT for Intermediate-advanced HCC

Sintilimab, Bevacizumab Plus Y-90 Selective Internal Radiation Therapy for Patients With Unresectable Intermediate-advanced Hepatocellular Carcinoma: a Prospective, Single-center, Single Arm Trial

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Enrollment

23 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma Non-resectable

Summary

This study is conducted to evaluate the efficacy and safety of sintilimab, bevacizumab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study combines sintilimab (an immune checkpoint drug), bevacizumab (a drug that cuts off blood supply to tumors), and SIRT (selective internal radiation therapy — tiny radioactive beads delivered inside the liver's blood vessels) for people with intermediate to advanced liver cancer (hepatocellular carcinoma, or HCC). **You may be eligible if...** - You have been diagnosed with intermediate or advanced hepatocellular carcinoma (liver cancer) - You have not previously received systemic therapy for liver cancer - Your liver is still functioning adequately (Child-Pugh A or early B) - You are at least 18 years old **You may NOT be eligible if...** - Your cancer has spread to distant organs (lungs, bones, etc.) in an uncontrolled way - You have portal vein invasion at the main trunk level - You have significant varices (enlarged veins in the esophagus) at risk of bleeding - You are on long-term steroids or immune-suppressing medications - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSin-Bev-SIRT

Sintilimab 200mg I.V. q3w and bevacizumab 7.5mg/kg I.V. q3w will be started at 3-7 days after the first SIRT. Treatment of sintilimab and bevacizumab will last up to 24 months. Patients will be allowed to have sintilimab or bevacizumab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.