Colorectal NeoplasmsNCT06079242
Observational Study for SIR-Spheres Therapy for the Treatment of Unresectable Metastatic Liver Tumors From Primary Colorectal Cancer
An observational study of Colorectal Neoplasms, run by GrandPharma (China) Co., Ltd. at 1 site in China.
Trial summary
This real-world study tries to collect data reflecting routine use of SIR-Spheres in patients diagnosed with unresectable liver metastases from Metastatic Liver Tumors From Primary Colorectal Cancer (mCRC) refractory to or intolerant to chemotherapy, in order to assess clinical response in a real-world setting and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Resin microspheres containing yttrium-90 (Y-90)
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2023to 1 Apr 2027
- How long will I take part?
- 24 Months
- 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: Unresectable metastatic liver tumors from primary colorectal cancer
Who may be able to join
- Obtained informed consent for patients to be follow-up prospectively
- Age≥18 years old
- Histologically or pathologically confirmed diagnosis of unresectable metastatic liver tumors from primary colorectal cancer and failed standard of care
- Received SIR-Spheres®
Who cannot join
- Special contraindications from package insert, which includes
- Markedly abnormal liver function tests, such as total bilirubin > 2.0 mg/dL or albumin <3.0 g/dL
- Portal vein thrombosis in the main trunk
- Disseminated extrahepatic disease
- Previous external beam radiation therapy to the liver
- Women are lactating or pregnant during the study or plan to be pregnant during the study
- Patients with mental illness or cognitive impairment
- Per investigator, patients are non-adherent or reluctant to be followed up
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
Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310002
hongming Pan, PhD, 0571-86006922, shonco@sina.cn
weidong Han, PhD, 0571-86006922, hanwd@zju.edu.cn
About this study
This real-world study tries to collect data reflecting routine use of SIR-Spheres in patients diagnosed with unresectable liver metastases from Metastatic Liver Tumors From Primary Colorectal Cancer (mCRC) refractory to or intolerant to chemotherapy, in order to assess clinical response in a real-world setting and further validate the safe and appropriate use of SIR-Spheres in China.
Read the detailed description
This is a post-market trial evaluating the efficacy and safety of SIR-Spheres® Y-90 resin microspheres for the treatment of unresectable metastatic liver tumors from primary colorectal cancer. Patients enrolled should already complete the infusion of SIR-Spheres® and data are about to be collected both retrospectively and prospectively. 200 patients are anticipated to be enrolled and followed up for up to 24 months.
- Conditions
- Colorectal Neoplasms
- Being tested
- Resin microspheres containing yttrium-90 (Y-90)
- Keywords
- Metastatic Colorectal Cancer, 90Y, Liver Metastases, SIRT, Radioembolization, SIR-Spheres Microspheres
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin microspheres containing yttrium-90 (Y-90)Device
Also called SIR-Spheres® Y-90
SIR-Spheres Y-90 resin microspheres are permanent implant and for single use only
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver-specific overall response rate (ORR) according to RECIST 1.1
Percentage of subjects with complete or partial responses to the liver as determined by the investigator according to liver-specific RECIST 1.1 criteria
Measured: 24 months
Secondary outcomes (7)
Overall survival (OS)
From the day of treatment with yttrium [90Y] resin microspheres to the time of death due to any cause
Measured: 24 months
1-yr OS
The percentage of subjects treated with yttrium [90Y] resin microspheres who survived at 1 year.
Measured: 12 months
Progression-free survival(PFS) assessed by the investigator
Defined as the time from the date of treatment with the yttrium [90Y] resin microspheres to the time when disease progression or subject death from any cause during the study period was first determined by the investigator according to RECIST 1.1 criteria, whichever occurred first.
Measured: 24 months
Liver-specific PFS assessed by the investigator
Defined as the time from the date of treatment with yttrium [90Y] resin microspheres until the first time progression of liver disease or death of the subject from any cause during the study period was determined by the investigator according to liver-specific RECIST 1.1 criteria, whichever occurred first.
Measured: 24 months
ORR assessed by the investigator
Defined as the percentage of subjects with complete or partial tumor response as determined by the investigator according to RECIST 1.1 criteria
Measured: 24 months
Objective Duration of tumor response (DOR) assessed by the investigator
Defined as the time from the first documented objective response to tumor recurrence or death from any cause during the study period as determined by the investigator according to RECIST 1.1 criteria, whichever occurs first
Measured: 24 months
Duration of liver-specific DOR assessed by the investigator
Defined as the time from the first documented liver objective remission to liver recurrence or death from any cause during the study period as determined by the investigator according to liver-specific RECIST 1.1 criteria, whichever occurs first
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start15 Oct 2023 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- Other
- Enrolment
- 200 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- GrandPharma (China) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079242
- Sponsor's protocol ID
- ST-GPL00102-CP001
- Status last verified
- Oct 2023
- First submitted
- 22 Sep 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study for SIR-Spheres Therapy for the Treatment of Unresectable Metastatic Liver Tumors From Primary Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06079242
- Acronym / sponsor ID
- ST-GPL00102-CP001
- Conditions
- Colorectal Neoplasms
- Keywords
- Metastatic Colorectal Cancer, 90Y, Liver Metastases, SIRT, Radioembolization, SIR-Spheres Microspheres
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- GrandPharma (China) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2023 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 12 Oct 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 real-world study tries to collect data reflecting routine use of SIR-Spheres in patients diagnosed with unresectable liver metastases from Metastatic Liver Tumors From Primary Colorectal Cancer (mCRC) refractory to or intolerant to chemotherapy, in order to assess clinical response in a real-world setting and further validate the safe and appropriate use of SIR-Spheres in China.
Detailed description
This is a post-market trial evaluating the efficacy and safety of SIR-Spheres® Y-90 resin microspheres for the treatment of unresectable metastatic liver tumors from primary colorectal cancer. Patients enrolled should already complete the infusion of SIR-Spheres® and data are about to be collected both retrospectively and prospectively. 200 patients are anticipated to be enrolled and followed up for up to 24 months.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Unresectable metastatic liver tumors from primary colorectal cancer
Key inclusion criteria (4 listed)
- Obtained informed consent for patients to be follow-up prospectively
- Age≥18 years old
- Histologically or pathologically confirmed diagnosis of unresectable metastatic liver tumors from primary colorectal cancer and failed standard of care
- Received SIR-Spheres®
Key exclusion criteria (8 listed)
- Special contraindications from package insert, which includes
- Women are lactating or pregnant during the study or plan to be pregnant during the study
- Patients with mental illness or cognitive impairment
- Per investigator, patients are non-adherent or reluctant to be followed up
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 |
|---|---|---|
| Resin microspheres containing yttrium-90 (Y-90)Also: SIR-Spheres® Y-90SIR-Spheres Y-90 resin microspheres are permanent implant and for single use only | Device | – |
Primary outcome
Liver-specific overall response rate (ORR) according to RECIST 1.1
Time frame: 24 months
Percentage of subjects with complete or partial responses to the liver as determined by the investigator according to liver-specific RECIST 1.1 criteria
7 secondary outcomes
Overall survival (OS)
Time frame: 24 months
1-yr OS
Time frame: 12 months
Progression-free survival(PFS) assessed by the investigator
Time frame: 24 months
Liver-specific PFS assessed by the investigator
Time frame: 24 months
ORR assessed by the investigator
Time frame: 24 months
Objective Duration of tumor response (DOR) assessed by the investigator
Time frame: 24 months
Duration of liver-specific DOR assessed by the investigator
Time frame: 24 months
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 13 Oct 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms, run by GrandPharma (China) Co., Ltd. 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 4 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: opening soon, as of the sponsor's last update on 13 Oct 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 Hui Wen, B.S. (027-84399665, huiwen@grandpharma.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver-specific overall response rate (ORR) according to RECIST 1.1 (time frame: 24 months). 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 13 Oct 2023.