Inoperable Hepatocellular Carcinoma Clinical Trial
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
To evaluate the efficacy and safety of TheraSphereTM yttrium [90Y] glass microsphere in the Chinese patients with inoperable hepatocellular carcinoma.
| Status | Recruiting |
| Enrollment | 90 |
| Est. completion date | October 30, 2026 |
| Est. primary completion date | June 30, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Zhongda Hospital Southeast University | Nanjing | Jiangsu |
| Lead Sponsor | Collaborator |
|---|---|
| Boston Scientific Corporation |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | Hepatic time to progression (hTTP) determined by localized mRECIST (within the treated area) | through study completion, an average of 18 months | ||
| Secondary | Objective response rate (ORR) of the index lesion according to localized mRECIST (within the treatment area) | through study completion, an average of 18 months | ||
| Secondary | Confirmed ORR according to mRECIST | through study completion, an average of 18 months | ||
| Secondary | OS (Overall Survival) | through study completion, an average of 18 months | ||
| Secondary | 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. | through study completion, an average of 18 months | |
| Secondary | 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. |
immediately after the procedure |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00872014 -
A Study of the Effectiveness and Safety of AMG 386 and Sorafenib to Treat Advanced or Inoperable Hepatocellular Cancer
|
Phase 2 |