MANDARIN (S6371)

Conditions: Inoperable Hepatocellular Carcinoma

Sex: All

Ages: 18 Years – 80 Years

Healthy volunteers: No

Phase: PHASE3

Enrollment: 92

Sponsor: Boston Scientific Corporation

Location: Zhongda Hospital Southeast University Nanjing Jiangsu

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\

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05016245). StuddyBuddy aggregates publicly available trial information.