A Pilot Study to Evaluate the Safety and Efficacy of Radiotherapy Plus Sintilimab for Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

Beijing Tsinghua Chang Gung Hospital1 site in 1 country20 target enrollmentNovember 25, 2019

ConditionsHepatocellular Carcinoma Portal Vein Tumor Thrombosis

InterventionsRadiotherapy Sintilimab

DrugsSintilimab

Overview

Phase: Phase 1
Intervention: Radiotherapy
Conditions: Hepatocellular Carcinoma
Sponsor: Beijing Tsinghua Chang Gung Hospital
Enrollment: 20
Locations: 1
Primary Endpoint: Incidence of treatment-emergent adverse events
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The proposed study is an open-label, single-center, single arm phase 1b study to evaluate the safety and efficacy of radiotherapy plus sintilimab for HCC with PVTT.

Detailed Description

The patients were divided into two groups. The first group: the single dose of radiotherapy was 200 cGy, once a day, the total dose was 5000 cGy. The second group: the single dose of radiotherapy was 300 cGy, once a day, and the total dose was 3000 cGy.

Registry

clinicaltrials.gov

Start Date

November 25, 2019

End Date

December 31, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Beijing Tsinghua Chang Gung Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Ability to understand and willingness to sign a written informed consent document.
•Locally advanced hepatocellular carcinoma with identified tumor thrombosis of main portal vein or primary branches (left and / or right branches)
•Has at least 1 measurable lesion
•Age ≥18 years
•Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
•Adequate organ function
•Child Pugh class A
•Life expectancy ≥12 weeks.
•Antiviral therapy per local standard of care for hepatitis B
•Woman of child bearing potential must have a negative pregnancy test

Exclusion Criteria

•Has previously been performed by raditotherapy for the area to be treated.
•With extrahepatic metastasis
•History of hepatic encephalopathy or liver transplantation
•Untreated hepatitis infection: HBV DNA\>2000IU/mlor10000 copy/ml, HCV RNA\> 1000copy/ml, both HbsAg and anti-HCV body are positive
•Has liver tumor not amenable to radiotherapy, or has had prior upper abdominal radiation therapy within planned volumes
•Has had esophageal or gastric variceal bleeding within 3 months prior to study enrollment
•With serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable
•Evidence of active pulmonary tuberculosis (TB)
•Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
•History of allergic reactions to related drugs