Hepatocellular Carcinoma Non-ResectablePhase 2NCT06707233
Y-90 SIRT for Unresectable HCC Larger Than 7cm
A Phase 2 study testing SIRT in people with Hepatocellular Carcinoma Non-Resectable, run by Second Affiliated Hospital of Guangzhou Medical University at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma Non-Resectable
- What is being tested?
- SIRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesChina
- Study dates
- 1 Dec 2024to 30 Nov 2027
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
Kangshun Zhu, Dr., +86-20-34156205, zhksh010@126.com
Kangshun Zhu, Dr.
- Recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
Mingyue Cai, Dr., +86-20-34156205, cai020@yeah.net
Kangshun Zhu, Dr., +86-20-34156205, zhksh010@163.com
About this study
Official title: Y-90 Selective Internal Radiation Therapy for Unresectable Hepatocellular Carcinoma Larger Than 7cm: a Prospective, Single Arm Trial
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).
- Conditions
- Hepatocellular Carcinoma Non-Resectable
- Being tested
- SIRT
- Keywords
- Hepatocellular Carcinoma, yttrium-90, selective internal radiation therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIRTProcedure or surgery
The patients will receive 1-2 sessions of SIRT.
| Study group | Role | What they receive |
|---|---|---|
| SIRT | Experimental | Patients will receive SIRT treatment Receives: Procedure: SIRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (7)
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
Measured: 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
Measured: 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.
Measured: 3 years
time to response (TTR)
The time from treatment initiation to first tumour remission (mRECIST and RECIST 1.1)
Measured: 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)
Measured: 3 years
Overall survival (OS)
The time from date of treatment initiation to death due to any cause
Measured: 4 years
Adverse Events (AEs)
Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events v5.0
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Dec 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma Non-ResectableStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707233
- Sponsor's protocol ID
- MIIR-17
- Status last verified
- Jan 2025
- First submitted
- 24 Nov 2024
- Last updated
- 28 Jan 2025
- 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 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Y-90 Selective Internal Radiation Therapy for Unresectable Hepatocellular Carcinoma Larger Than 7cm: a Prospective, Single Arm Trial
- ClinicalTrials.gov ID
- NCT06707233
- Acronym / sponsor ID
- MIIR-17
- Conditions
- Hepatocellular Carcinoma Non-Resectable
- Keywords
- Hepatocellular Carcinoma, yttrium-90, selective internal radiation therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 27 Nov 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIRT | Experimental | Procedure: SIRTPatients will receive SIRT treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| SIRTThe patients will receive 1-2 sessions of SIRT. | Procedure or surgery | SIRT |
Primary outcome
Objective response rate (ORR) per mRECIST
Time frame: 3 years
The proportion of patients with the best response of complete response (CR) or partial response (PR) according to mRECIST
7 secondary outcomes
Objective response rate (ORR) per RECIST 1.1
Time frame: 3 years
Disease control rate (DCR)
Time frame: 3 years
Progression free survival (PFS)
Time frame: 3 years
time to response (TTR)
Time frame: 3 years
Duration of response (DOR)
Time frame: 3 years
Overall survival (OS)
Time frame: 4 years
Adverse Events (AEs)
Time frame: 3 years
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 28 Jan 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SIRT in people with Hepatocellular Carcinoma Non-Resectable, run by Second Affiliated Hospital of Guangzhou Medical University at 2 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 10 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Mingyue Cai, Dr. (+86-20-34156205, cai020@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) per mRECIST (time frame: 3 years). 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 28 Jan 2025.