Clinical trial NCT05016245: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Inoperable Hepatocellular Carcinoma
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2021-08-23
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Time to progression (TTP)
timeFrame: through study completion, an average of 18 months
measure: Safety assessed within 60 days post treatment using NCI-CTCAE v5.0
timeFrame: within 60 days post treatment
Secondary outcomes:
measure: Hepatic time to progression (hTTP) determined by localized mRECIST (within the treated area)
timeFrame: through study completion, an average of 18 months
measure: Objective response rate (ORR) of the index lesion according to localized mRECIST (within the treatment area)
timeFrame: through study completion, an average of 18 months
measure: Confirmed ORR according to mRECIST
timeFrame: through study completion, an average of 18 months
measure: OS (Overall Survival)
timeFrame: through study completion, an average of 18 months
measure: Safety assessed using NCI-CTCAE v 5.0
timeFrame: through study completion, an average of 18 months
measure: Procedure technical success
timeFrame: immediately after the procedure
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Gaojun TENG, Dr.
role: PRINCIPAL_INVESTIGATOR
References: