Sintilimab Plus Bevacizumab and SIRT for Intermediate-advanced HCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital of Guangzhou Medical University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Unresectable HCC (BCLC stage B/C or CNLC II/III) with diagnosis confirmed by histology/cytology or clinically
At least one measurable untreated lesion
Intrahepatic tumors can be treated with 1-2 sessions of SIRT
Child-Pugh score 5-7
Disqualifiers
tumor extent ≥70% liver occupation
Tumor thrombus involving main portal vein or both the first left and right branches of portal vein
Vena cava invasion
Central nervous system metastasis
Trial design
Design model
Single group
Treatments tested in this trial
Sin-Bev-SIRT
DrugSintilimab 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.
Treatment groups
23 Participants
are divided into 1 treatment groupGroup A: Sin-Bev-SIRTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression free survival (PFS) according to mRECIST
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Time frame
3 yearsSecondary outcomes
1
Progression free survival (PFS) according to RECIST 1.1
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Time frame
3 years2
Objective response rate (ORR)
The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR) according to mRECIST and RECIST 1.1
Time frame
3 years3
Disease control rate (DCR)
The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD) according to mRECIST and RECIST 1.1
Time frame
3 years4
Overall survival (OS)
The time from initiation of treatment until the date of death from any cause.
Time frame
3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov