Trials Sponsors Conditions Drugs Pricing

Conditions

Inoperable Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

Time to progression (TTP)
Time to progression (TTP) Definition of progression: Progressive Disease (PD) assessment occurs according to mRECIST occurs according to mRECIST
through study completion, an average of 18 months
Safety assessed within 60 days post treatment using NCI-CTCAE v5.0
Safety assessed within 60 days post treatment using NCI-CTCAE v5.0
within 60 days post treatment

Secondary Outcomes (6)

Hepatic time to progression (hTTP) determined by localized mRECIST (within the treated area)
through study completion, an average of 18 months
Objective response rate (ORR) of the index lesion according to localized mRECIST (within the treatment area)
through study completion, an average of 18 months
Confirmed ORR according to mRECIST
through study completion, an average of 18 months
OS (Overall Survival)
through study completion, an average of 18 months
Safety assessed using NCI-CTCAE v 5.0
through study completion, an average of 18 months
+1 more secondary outcomes

Study Arms (2)

TheraSphere™ Yttrium-90 Glass Microspheres

EXPERIMENTAL

Combination Product: TheraSphere™ Yttrium-90 Glass Microspheres

conventional Transarterial Chemoembolization(cTACE)

ACTIVE COMPARATOR

Procedure: conventional Transarterial Chemoembolization(cTACE)

Interventions

TheraSphere™ Yttrium-90 Glass MicrospheresCombination product

TheraSphere™ Yttrium-90 Glass Microspheres TheraSphere™ is steam sterilized and supplied in 6 standard dose sizes: 3 GBq, 5 GBq, 7 GBq, 10 GBq, 15 GBq, 20 GBq. Custom dose sizes are also available in 0.5 GBq increments between 3 and 20 GBq. TheraSphereTM is supplied with the following accessories: Administration Set Administration Accessory Kit

TheraSphere™ Yttrium-90 Glass Microspheres

conventional Transarterial Chemoembolization(cTACE)Procedure

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

≥18 and ≤80 age and provided study consent
Patients diagnosed with HCC and clinically evaluated as inoperable (as per local practice) or who refuse operation (ablation, hepatectomy and liver transplantation)

Sponsors & Collaborators

Boston Scientific Corporation
Industrylead

Study Sites (1)

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009, China

Study Officials

Gaojun TENG, Dr.
Zhongda Hospital
PRINCIPAL INVESTIGATOR

Enrollment

92 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 9, 2021

First Posted

August 23, 2021

Study Start

September 13, 2021

Actual (reported)

MANDARIN (S6371)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (6)

Study Arms (2)

TheraSphere™ Yttrium-90 Glass Microspheres

conventional Transarterial Chemoembolization(cTACE)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (6)

Study Arms (2)

TheraSphere™ Yttrium-90 Glass Microspheres

conventional Transarterial Chemoembolization(cTACE)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations