Clinical trial NCT06712017: Observational Study for SIR-Spheres Therapy for the Treatment of HCC Patients in China
Official title: A Descriptive, Retrospective, Single-Arm Cohort Study on the Use of Selective Internal Radiation Therapy (SIRT) with Yttrium-90 Microspheres for Unresectable Primary Hepatocellular Carcinoma (HCC) in the Chinese Population
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma Non-Resectable
Keywords: yttrium 90
y-90
HCC
SIRT
Lead sponsor: GrandPharma (China) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult HCC patients treated with yttrium-90 during 2023.1.1 - 2024.6.30 and assessed at least once for tumor response within 6 months following treatment

Brief summary: Yttrium-90 (y90) Microsphere Injection Solution was approved by the NMPA in 2022. Currently, there is a lack of summary of real-world data in China. Therefore, this retrospective real-world study is intented to explore the characteristics and efficacy of HCC patients treated with y90 in China, aiming to provide reference for guiding and optimizing clinical practices and subsequent confirmatory clinical studies for the treatment of HCC patients in China.


Eligibility criteria: Inclusion Criteria:

1. age ≥ 18 years old;
2. confirmed diagnosis of HCC
3. treated with yttrium-90 during 2023.1.1 - 2024.6.30 and assessed at least once for tumor response within 6 months following treatment

Exclusion Criteria:

no formal exclusion criteria in a real-world study

Primary outcomes:
measure: best hepatic ORR measured by mRECIST criteria
timeFrame: 6 months following y90 therapy
Secondary outcomes:
measure: ORR measured by mRECIST criteria
timeFrame: 6 months following y90 therapy
measure: OS
timeFrame: From date of first Y90 therapy until the date of death from any cause, assessed up to 24 months
measure: TTP
timeFrame: From date of first Y90 therapy until the date of first documented progression, assessed up to 24 months
measure: PFS
timeFrame: From date of first Y90 therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: 6 months following y90 therapy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Jinan
country: China
facility: The First Affiliated Hospital of Jinan University
state: Guangdong
city: Xi'An
country: China
facility: Xi'An International Medical Center Hospital
state: Guangxi
city: Xi'An
country: China
facility: No.1 Affiliated Hospital of Xian Jiaotong University
state: Shanxi
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
city: Shanghai
country: China
facility: The Third Affiliated Hospital of Naval Medical University
Study officials:
affiliation: Beijing Tsinghua Changgeng Hospital
name: Xiaobin Feng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Affiliated Hospital of Guangzhou Medical University
name: Kangshun Zhu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Third Affiliated Hospital of Naval Medical University
name: Yefa Yang, MD
role: PRINCIPAL_INVESTIGATOR
References: