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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06712017
- Acronym / sponsor ID
- ST-GPN00561-CP001
- Keywords
- yttrium 90, y-90, HCC, SIRT
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- GrandPharma (China) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 2 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult HCC patients treated with yttrium90 | – | Device: Yttrium-90 (Y-90) resin microspheres |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- no formal exclusion criteria in a real-world study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yttrium-90 (Y-90) resin microspheresselective internal radiation therapy | Device | adult HCC patients treated with yttrium90 |
Primary outcome
best hepatic ORR measured by mRECIST criteria
Time frame: 6 months following y90 therapy
5 secondary outcomes
ORR measured by mRECIST criteria
Time frame: 6 months following y90 therapy
OS
Time frame: From date of first Y90 therapy until the date of death from any cause, assessed up to 24 months
TTP
Time frame: From date of first Y90 therapy until the date of first documented progression, assessed up to 24 months
PFS
Time frame: 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
Time frame: 6 months following y90 therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaobin Feng, MD principal investigator
Beijing Tsinghua Changgeng Hospital
Kangshun Zhu, MD principal investigator
Second Affiliated Hospital of Guangzhou Medical University
Yefa Yang, MD principal investigator
Eastern Hepatobiliary Surgery Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma (HCC) and Hepatocellular Carcinoma Non-Resectable, run by GrandPharma (China) Co., Ltd. at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
best hepatic ORR measured by mRECIST criteria (time frame: 6 months following y90 therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.