Hepatocellular Carcinoma (HCC)NCT06712017
Observational Study for SIR-Spheres Therapy for the Treatment of HCC Patients in China
An observational study of Hepatocellular Carcinoma (HCC) and Hepatocellular Carcinoma Non-Resectable, run by GrandPharma (China) Co., Ltd. at 6 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Hepatocellular Carcinoma Non-Resectable
- What is being tested?
- Yttrium-90 (Y-90) resin microspheres
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 6 sitesChina
- Study dates
- 22 Aug 2024to 30 Jun 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- age ≥ 18 years old;
- confirmed diagnosis of HCC
- treated with yttrium-90 during 2023.1.1 - 2024.6.30 and assessed at least once for tumor response within 6 months following treatment
Who cannot join
- no formal exclusion criteria in a real-world study
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites
Beijing Tsinghua Changgung Hospital
Beijing
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
The First Affiliated Hospital of Jinan University
Jinan, Guangdong
The Third Affiliated Hospital of Naval Medical University
Shanghai
Xi'An International Medical Center Hospital
Xi’an, Guangxi
No.1 Affiliated Hospital of Xian Jiaotong University
Xi’an, Shanxi
About this study
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
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.
- Being tested
- Yttrium-90 (Y-90) resin microspheres
- Keywords
- yttrium 90, y-90, HCC, SIRT
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yttrium-90 (Y-90) resin microspheresDevice
selective internal radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| adult HCC patients treated with yttrium90 | Not described Receives: Device: Yttrium-90 (Y-90) resin microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
best hepatic ORR measured by mRECIST criteria
Measured: 6 months following y90 therapy
Secondary outcomes (5)
ORR measured by mRECIST criteria
Measured: 6 months following y90 therapy
OS
Measured: From date of first Y90 therapy until the date of death from any cause, assessed up to 24 months
TTP
time to progression
Measured: From date of first Y90 therapy until the date of first documented progression, assessed up to 24 months
PFS
Measured: 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
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: 6 months following y90 therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start22 Aug 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GrandPharma (China) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaobin Feng, MD, Principal investigator, Beijing Tsinghua Changgeng HospitalKangshun Zhu, MD, Principal investigator, Second Affiliated Hospital of Guangzhou Medical UniversityYefa Yang, MD, Principal investigator, Eastern Hepatobiliary Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712017
- Sponsor's protocol ID
- ST-GPN00561-CP001
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided