Y-90 SIRT for Unresectable HCC Larger Than 7cm

Phase 2RecruitingNCT06707233

Second Affiliated Hospital of Guangzhou Medical University33 enrolled

Overview

This is a phase II clinical study to evaluate the efficacy and safety of SIRT in patients with HCC greater than 7 cm. After enrollment, patients received yttrium-90 selective internal radiation therapy. The primary endpoint of the study is objective reponse rate (ORR) as assessed by mRECIST. Secondary endpoints were: objective response rate (ORR) as assessed by RECIST 1.1, disease control rate (DCR), progression-free survival (PFS), time to response (TTR), duration of response (DOR), overall survival (OS), and safety (incidence and severity of adverse events).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatocellular Carcinoma Non-Resectable

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pathologically confirmed or clinically diagnosed HCC * Unresectable HCC as assessed by a team of surgeons * The largest tumor size \> 7 cm * Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment * At least one measurable intrahepatic target lesion * Appropriate for SIRT treatment after evaluation (including SPECT/CT evaluation after arterial perfusion with 99Tc-MAA) * Child-Pugh score ≤ 7 * ECOG PS ≤ 1 * Adequate organ and hematologic function with platelet count ≥75×10\^9/L, leukocyte \>3.0×10\^9/L, Neutrophil count ≥1.5×10\^9/L, haemoglobin ≥85 g/L, ALT and AST≤5×ULN, creatinine≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds * life expectancy of at least 6 months Exclusion Criteria: * Macrovascular invasion or extrahepatic metastasis * Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy * Organ (heart and kidneys) dysfunction * History of other malignancies * Uncontrollable infection * History of organ or cells transplantation * History of HIV * Pregnant or lactating patients

Locations (2)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

NOT_YET_RECRUITING

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

Objective response rate (ORR) per mRECIST

The proportion of patients with the best response of complete response (CR) or partial response (PR) according to mRECIST

Time frame: 3 years

Secondary Outcomes

Objective response rate (ORR) per RECIST 1.1

The proportion of patients with the best response of complete response (CR) or partial response (PR) according to RECIST 1.1

Time frame: 3 years

Disease control rate (DCR)

The proportion of patients with the best response of CR, PR, or stable disease (SD) according to mRECIST and RECIST 1.1

Time frame: 3 years

Progression free survival (PFS)

The time from date of treatment initiation until the first occurrence of disease progression (according to mRECIST and RECIST 1.1) or death due to any cause, whichever occurs first.

Time frame: 3 years

time to response (TTR)

The time from treatment initiation to first tumour remission (mRECIST and RECIST 1.1)

Time frame: 3 years

Duration of response (DOR)

Time from first tumor response to first disease progression (mRECIST and RECIST 1.1 assessment) or death from any cause (whichever occurs first)

Time frame: 3 years

Overall survival (OS)

The time from date of treatment initiation to death due to any cause

Time frame: 4 years

Adverse Events (AEs)

Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events v5.0

Time frame: 3 years

Central Contacts

Mingyue Cai, Dr.

CONTACT

+86-20-34156205 cai020@yeah.net

Kangshun Zhu, Dr.

CONTACT

+86-20-34156205 zhksh010@163.com