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MANDARIN (S6371)

Primary Purpose

Inoperable Hepatocellular Carcinoma

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

TheraSphere™ Yttrium-90 Glass Microspheres

conventional Transarterial Chemoembolization(cTACE)

About this trial

This is an interventional treatment trial for Inoperable Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

≥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)
At least one well defined HCC tumor measurable by mRECIST in contrast-enhanced MRI
China liver cancer staging (CNLC) stage Ib~IIb
Child-Pugh ≤ B7
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Tumor burden ≤50% of the total liver volume

Exclusion Criteria:

Presence of extra-hepatic metastases or additional malignancies aside from HCC
Patients with hepatic artery malformation and unable to intubate hepatic artery
Patients who are allergic to contrast agents or have renal insufficiency (Serum creatinine>2mg/ml or Creatinine clearance<30mL/min) and are not suitable for injection of contrast agents
Severe pulmonary insufficiency (FEV1/FVC<50% or FEV1/predicting value<50% or MVV<50L/min)
AST and ALT >5 times upper limit of normal
Clinical manifestations of decompensated cirrhosis (Grade2/3 of ascites, gastrointestinal bleeding, hepatic encephalopathy, etc. according to EASL Clinical Practice Guidelines)
HCC invading biliary tract or causing biliary obstruction
uncorrectable coagulation dysfunction and severe hemogram abnormality [Prothrombin time (PT)>6 seconds above control or PT-International normalized ratio (INR)>2.5, WBC<3.0x109/L, PLT<50x109/L]
Infiltrative HCC tumor type
Bilobar HCC disease
Any presence of portal vein or hepatic veins or artery invasion
Occlusion of portal vein completely with less collateral vessels
Transjugular intrahepatic portosystemic shunt (TIPS) or Hepatic arterioportal fistula
Patients during pregnancy or lactation
Prior interventional therapy via hepatic artery or radiotherapy treatment for HCC
Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy shows any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques
Radiation pneumonitis has been seen in patients receiving doses to the lungs greater than 30 Gy in a single treatment or greater than 50Gy in multiple treatment
The absorbed dose of lung may exceed 30Gy in preoperative evaluation
Receive any investigational therapy or anti-tumor therapy within 30 days prior to study enrollment
Any other reason in which the investigator believes that the patient is unsuitable to participate in this trial

Sites / Locations

Zhongda Hospital Southeast UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TheraSphere™ Yttrium-90 Glass Microspheres

conventional Transarterial Chemoembolization(cTACE)

Arm Description

Outcomes

Primary Outcome Measures

Time to progression (TTP)

Time to progression (TTP) Definition of progression: Progressive Disease (PD) assessment occurs according to mRECIST occurs according to mRECIST

Safety assessed within 60 days post treatment using NCI-CTCAE v5.0

Secondary Outcome Measures

Hepatic time to progression (hTTP) determined by localized mRECIST (within the treated area)

Objective response rate (ORR) of the index lesion according to localized mRECIST (within the treatment area)

Confirmed ORR according to mRECIST

OS (Overall Survival)

Safety assessed using NCI-CTCAE v 5.0

Safety assess: to standardize reporting, the National Cancer Institute Common Terminology Criteria (NCI CTCAE), version 5, was used to grade AEs and SAEs. Grades 1, 2, 3, and 4 represented mild, moderate, severe, and life-threatening toxicity, respectively. Grade 5 represented toxicity resulting in death. Descriptive analyses were conducted to assess the safety in each grade and summarized as the number of events and rate per subject.

Procedure technical success

Procedure technical success is determined successfully if all three items are satisfied at the same time during the operation as follow: Device connected successfully or not; Microspheres or anti-neoplastic agent(s) (i.e. cisplatin), lipiodol and embolic agent(s). deliver to target area well, or not by device parts; There was no unplanned release of radiation or leakage of neoplastic agent(s) (i.e. cisplatin), lipiodol and embolic agent(s), or not by device parts.

Full Information

NCT ID

NCT05016245

First Posted

August 9, 2021

Last Updated

October 9, 2023

Sponsor

Boston Scientific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT05016245

Brief Title

MANDARIN (S6371)

Official Title

A Multicentre, Prospective, Open-label, Randomized Controlled Trial on the Efficacy and Safety of TheraSphereTM (Yttrium-90 Glass Microspheres) Compared to Conventional Transarterial Chemoembolization (cTACE) in Chinese Patients With Inoperable Hepatocellular Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 13, 2021 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

To evaluate the efficacy and safety of TheraSphereTM yttrium [90Y] glass microsphere in the Chinese patients with inoperable hepatocellular carcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inoperable Hepatocellular Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TheraSphere™ Yttrium-90 Glass Microspheres

Arm Type

Experimental

Arm Title

conventional Transarterial Chemoembolization(cTACE)

Arm Type

Active Comparator

Intervention Type

Combination Product

Intervention Name(s)

TheraSphere™ Yttrium-90 Glass Microspheres

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

conventional Transarterial Chemoembolization(cTACE)

Intervention Description

conventional Transarterial Chemoembolization(cTACE) is comprised of an anti-neoplastic agent(s) (i.e. cisplatin), lipiodol and embolic agent(s). The choice of agent(s) to be used is per usual local site practice. Chemotherapy agents can be as a single agent or used in combination, as per local practice.

Primary Outcome Measure Information:

Title

Time to progression (TTP)

Description

Time to progression (TTP) Definition of progression: Progressive Disease (PD) assessment occurs according to mRECIST occurs according to mRECIST

Time Frame

through study completion, an average of 18 months

Title

Safety assessed within 60 days post treatment using NCI-CTCAE v5.0

Description

Safety assessed within 60 days post treatment using NCI-CTCAE v5.0

Time Frame

within 60 days post treatment

Secondary Outcome Measure Information:

Title

Hepatic time to progression (hTTP) determined by localized mRECIST (within the treated area)

Time Frame

through study completion, an average of 18 months

Title

Objective response rate (ORR) of the index lesion according to localized mRECIST (within the treatment area)

Time Frame

through study completion, an average of 18 months

Title

Confirmed ORR according to mRECIST

Time Frame

through study completion, an average of 18 months

Title

OS (Overall Survival)

Time Frame

through study completion, an average of 18 months

Title

Safety assessed using NCI-CTCAE v 5.0

Description

Time Frame

through study completion, an average of 18 months

Title

Procedure technical success

Description

Time Frame

immediately after the procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ≥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) At least one well defined HCC tumor measurable by mRECIST in contrast-enhanced MRI China liver cancer staging (CNLC) stage Ib~IIb Child-Pugh ≤ B7 Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 Tumor burden ≤50% of the total liver volume Exclusion Criteria: Presence of extra-hepatic metastases or additional malignancies aside from HCC Patients with hepatic artery malformation and unable to intubate hepatic artery Patients who are allergic to contrast agents or have renal insufficiency (Serum creatinine>2mg/ml or Creatinine clearance<30mL/min) and are not suitable for injection of contrast agents Severe pulmonary insufficiency (FEV1/FVC<50% or FEV1/predicting value<50% or MVV<50L/min) AST and ALT >5 times upper limit of normal Clinical manifestations of decompensated cirrhosis (Grade2/3 of ascites, gastrointestinal bleeding, hepatic encephalopathy, etc. according to EASL Clinical Practice Guidelines) HCC invading biliary tract or causing biliary obstruction uncorrectable coagulation dysfunction and severe hemogram abnormality [Prothrombin time (PT)>6 seconds above control or PT-International normalized ratio (INR)>2.5, WBC<3.0x109/L, PLT<50x109/L] Infiltrative HCC tumor type Bilobar HCC disease Any presence of portal vein or hepatic veins or artery invasion Occlusion of portal vein completely with less collateral vessels Transjugular intrahepatic portosystemic shunt (TIPS) or Hepatic arterioportal fistula Patients during pregnancy or lactation Prior interventional therapy via hepatic artery or radiotherapy treatment for HCC Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy shows any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques Radiation pneumonitis has been seen in patients receiving doses to the lungs greater than 30 Gy in a single treatment or greater than 50Gy in multiple treatment The absorbed dose of lung may exceed 30Gy in preoperative evaluation Receive any investigational therapy or anti-tumor therapy within 30 days prior to study enrollment Any other reason in which the investigator believes that the patient is unsuitable to participate in this trial

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yuwei ZHANG

Phone

+86-10-85216440

Yuwei.zhang@bsci.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhiyu ZENG, Dr.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gaojun TENG, Dr.

Organizational Affiliation

Zhongda Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongda Hospital Southeast University

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210009

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gaojun TENG, Dr.

12. IPD Sharing Statement

Plan to Share IPD

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MANDARIN (S6371)

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