Sintilimab and Bevacizumab Combined With Radiotherapy in the Treatment of Advanced Hepatocellular Carcinoma

Sun Yat-sen University1 site in 1 country46 target enrollmentAugust 16, 2021

ConditionsHepatocellular Carcinoma

InterventionsSintilimab and Bevacizumab Combined with Radiotherapy

DrugsSintilimab and Bevacizumab Combined with Radiotherapy

Overview

Phase: Phase 2
Intervention: Sintilimab and Bevacizumab Combined with Radiotherapy
Conditions: Hepatocellular Carcinoma
Sponsor: Sun Yat-sen University
Enrollment: 46
Locations: 1
Primary Endpoint: ORR (objective response rate)
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to investigate both the efficacy and safety of sintilimab combined with bevacizumab and radiotherapy in advanced hepatocellular carcinoma.

Registry

clinicaltrials.gov

Start Date

August 16, 2021

End Date

September 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Zhen-Wei Peng

Associate Professor

First Affiliated Hospital, Sun Yat-Sen University

Eligibility Criteria

Inclusion Criteria

•Age 18-75 years;
•Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
•Treatment-naïve primary HCC (consistent with the American Association for the Study of Liver Diseases 2018 Guideline on Liver Cancer Diagnosis (18)) or initial recurrent HCC after radical resection without any postoperative anti-cancer treatment;
•At least one measurable lesion in the liver on the basis of modified Response Evaluation Criteria in Solid Tumors (mRECIST);
•Presented with Cheng's type I/II/III PVTT;
•Largest tumor size ≤ 10 cm, number of tumors ≤ 3, and remnant liver volume ≥ 50%;
•Child-Pugh class A;
•Adequate hematological, liver, renal function:
•hemoglobin concentration ≥ 90 g/L;
•neutrophil count ≥ 1.5×109/L;

Exclusion Criteria

•Tumor invasion of the superior mesenteric vein or bile ducts;
•Infiltrative HCC;
•Allergic to research reagents;
•With other malignancies within 5 years;
•With poorly controlled hypertension;
•A past medical history of hepatic decompensation, such as hepatic encephalopathy, refractory ascites, and esophageal or gastric variceal bleeding;
•A history of autoimmune disease;
•Active infection requiring systemic treatments;
•Severe bleeding;
•With diseases needing daily non-steroidal anti-inflammatory drug (NSAID) therapy;