Hepatocellular CarcinomaNCT05994859
SIRT for Potentially Resectable HCC
A study testing SIRT in people with Hepatocellular Carcinoma, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This study is conducted to evaluate the efficacy and safety of Y-90 selective internal radiation therapy (SIRT) in patients with potentially resectable hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- 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
- 35 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2023to 9 Feb 2027
- Phase
- Interventional
- 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
- HCC with diagnosis confirmed pathologically or clinically
- No pervious treatment for HCC
- At least one measurable intrahepatic target lesion
- Potentially resectable HCC: tumor(s) confined to the left/right hemiliver, with/without invasion to the unilateral branch of the portal vein and/or hepatic vein
- Disease amenable to SIRT (after evaluation)
- Child-Pugh Class A or without cirrhosis
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- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA<10^3 IU/mL
- Patients with hepatitis C need to finish the anti-HCV treatment
- Adequate organ and bone marrow function; the blood biochemical examination: platelet count ≥75×10^9/L, white blood cell count >3.0×10^9/L, absolute value of neutrophils >1.5×10^9/L, hemoglobin ≥85 g/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR<1.5 or PT/APTT normal range
- Life expectancy of at least 6 months
Who cannot join
- Tumor involving main portal vein, bilateral branches of portal vein, or vena cava
- tumor extention beyond one lobe of the liver
- Bilobar tumor distribution
- Extrahepatic metastasis
- Decompensated liver function, including ascites, bleeding from esophageal and gastric varices, and/or hepatic encephalopathy
- Organ (heart, kidney) dysfunction
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- HBsAg and anti-HCV antibody positive concurrently
- History of malignancy other than HCC
- Uncontrolled infection
- History of HIV
- History of organ and cell transplantation
- Patients with bleeding tendency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
Kangshun Zhu, Dr., +86-20-34156205, zhksh010@126.com
Kangshun Zhu, Dr.
About this study
Official title: Y-90 Selective Internal Radiation Therapy for Potentially Resectable Hepatocellular Carcinoma: a Prospective, Single Arm Trial
This study is conducted to evaluate the efficacy and safety of Y-90 selective internal radiation therapy (SIRT) in patients with potentially resectable hepatocellular carcinoma (HCC).
Read the detailed description
This is a bi-center, prospective study to evaluate the efficacy and safety of SIRT in patient with potentially resectable HCC.
35 patients with potentially resectable (initially unresectable) HCC will be enrolled in this study. The patients will receive 1-2 sessions of SIRT. If the patients have invasive tumors, extensive liver involvement or vascular invasion, systematic treatment will be added. If the patients are evaluated as resectable during follw-up, liver resection will be recommended.
The primary end point of this study is success rate of conversion to resection. The secondary endpoints are objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), time to progression (TTP), duration of response (DOR), overall survival (OS) and adverse events (AEs).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- SIRT
- Keywords
- Hepatocellular Carcinoma, unresectable, 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. If the patients have invasive tumors, extensive liver involvement or vascular invasion, systematic treatment will be added.
| Study group | Role | What they receive |
|---|---|---|
| SIRT | Experimental | Treatment with SIRT. Receives: Procedure: SIRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of conversion to resection
The proportion of patients with initially unresectable HCC who were evaluated by the surgical team as suitable for second-stage surgical resection after SIRT
Measured: 3 years
Secondary outcomes (7)
Objective response rate (ORR)
The percentage of patients who have a best overall tumor response rating of complete response (CR) or partial response (PR)
Measured: 3 years
Disease control rate (DCR)
The percentage of patients who have a tumor response rating of CR, PR, or stable disease (SD)
Measured: 3 years
Progression-free survival (PFS)
The time between the first treatment and the first occurrence of disease progression (PD) or death from any cause, whichever occurs first
Measured: 3 years
Time to progression (TTP)
the time interval from first treatment to the first occurrence of disease progression
Measured: 3 years
Duration of response (DOR)
the time from initial objective response (CR or PR) until PD or death, whichever occurs first
Measured: 3 years
Overall survival (OS)
The time from initiation of treatment until the date of death from any cause
Measured: 3 years
Adverse Events (AEs)
Number of patients with AEs assessed by NCI CTCAE 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 posted16 Aug 2023
- Study start10 Aug 2023
- Primary completion9 Aug 2026 (estimated)
- Study completion9 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994859
- Sponsor's protocol ID
- MIIR-15
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Y-90 Selective Internal Radiation Therapy for Potentially Resectable Hepatocellular Carcinoma: a Prospective, Single Arm Trial
- ClinicalTrials.gov ID
- NCT05994859
- Acronym / sponsor ID
- MIIR-15
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, unresectable, selective internal radiation therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 9 Aug 2026 (estimated)
- Study completion
- 9 Feb 2027 (estimated)
- First posted
- 16 Aug 2023 (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 study is conducted to evaluate the efficacy and safety of Y-90 selective internal radiation therapy (SIRT) in patients with potentially resectable hepatocellular carcinoma (HCC).
Detailed description
This is a bi-center, prospective study to evaluate the efficacy and safety of SIRT in patient with potentially resectable HCC.
35 patients with potentially resectable (initially unresectable) HCC will be enrolled in this study. The patients will receive 1-2 sessions of SIRT. If the patients have invasive tumors, extensive liver involvement or vascular invasion, systematic treatment will be added. If the patients are evaluated as resectable during follw-up, liver resection will be recommended.
The primary end point of this study is success rate of conversion to resection. The secondary endpoints are objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), time to progression (TTP), duration of response (DOR), overall survival (OS) and adverse events (AEs).
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: SIRTTreatment with SIRT. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- HCC with diagnosis confirmed pathologically or clinically
- No pervious treatment for HCC
- At least one measurable intrahepatic target lesion
- Potentially resectable HCC: tumor(s) confined to the left/right hemiliver, with/without invasion to the unilateral branch of the portal vein and/or hepatic vein
- Disease amenable to SIRT (after evaluation)
Key exclusion criteria (12 listed)
- Tumor involving main portal vein, bilateral branches of portal vein, or vena cava
- tumor extention beyond one lobe of the liver
- Bilobar tumor distribution
- Extrahepatic metastasis
- Decompensated liver function, including ascites, bleeding from esophageal and gastric varices, and/or hepatic encephalopathy
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. If the patients have invasive tumors, extensive liver involvement or vascular invasion, systematic treatment will be added. | Procedure or surgery | SIRT |
Primary outcome
Success rate of conversion to resection
Time frame: 3 years
The proportion of patients with initially unresectable HCC who were evaluated by the surgical team as suitable for second-stage surgical resection after SIRT
7 secondary outcomes
Objective response rate (ORR)
Time frame: 3 years
Disease control rate (DCR)
Time frame: 3 years
Progression-free survival (PFS)
Time frame: 3 years
Time to progression (TTP)
Time frame: 3 years
Duration of response (DOR)
Time frame: 3 years
Overall survival (OS)
Time frame: 3 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 14 Sep 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIRT in people with Hepatocellular Carcinoma, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site 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 11 inclusion and 12 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 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Success rate of conversion to resection (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 14 Sep 2023.