Colorectal Cancer MetastaticNCT06447727
Efficacy and Safety of 90Y Microsphere Combined With FOLFIRI and Bevacizumab in Second-line Treatment of CRLM
An observational study of Colorectal Cancer Metastatic, run by Zhongda Hospital at 1 site in China.
Trial summary
To observe the PFS of yttrium [90Y] microsphere injection combined with FOLFIRI and bevacizumab in second-line treatment of CRLM. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- SIRT with Yttrium-90 Microspheres and FOLFIRI and Bevacizumab
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2024to 30 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with liver metastasis of colorectal cancer
Who may be able to join
- 18 years old≤ age ≤ 75 years old
- Voluntarily signed informed consent
- Patients with liver metastases of colorectal cancer, colorectal cancer lesions have resection, liver metastases limited to a single lobe
- The liver tumor progresses after first-line treatment, and FOLFIRI combined with bevacizumab therapy is planned
- On the assessment of the clinician, the patient was eligible for yttrium [90Y] microspheres injection, and treatment with yttrium [90Y] microspheres injection was planned
- KRAS mutant
Show all 9Show fewer
- ECOG PS: 0-1
- Child Pugh score ≤7
- Adequate level of organ function：a) Hematology: Neutrophils (ANC) ≥1.5×109/L, hemoglobin (HB) ≥90 g/L, platelets (PLT) ≥75×109/L；b) Liver function: albumin > 3 g/dL; ALT and AST≤ 5 x ULN; TBIL < 34.0 μmol/L；c) Renal function: serum creatinine ≤176.8 μmol/L or endogenous creatinine clearance > 50 mL/min；d) Coagulation function: INR≤1.2.
Who cannot join
- After liver metastasis was diagnosed, the liver underwent external radiation therapy and transhepatic arterial chemoembolization
- Patients with extrahepatic metastases
- Pregnant and lactating women
- History of severe arrhythmia or heart failure
- Other researchers considered it inappropriate to participate in this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital，Southeast University
Nanjing, Jiangsu, 210009
Hai-Dong Zhu
About this study
Official title: Efficacy and Safety of 90Y Microsphere Combined With FOLFIRI and Bevacizumab in Second-line Treatment of Colorectal Cancer Liver Metastasis
To observe the PFS of yttrium [90Y] microsphere injection combined with FOLFIRI and bevacizumab in second-line treatment of CRLM.
Read the detailed description
This study is a prospective, multicenter, observational, cohort study to observe the efficacy and safety of selective internal radiation therapy (SIRT) with yttrium [90Y] microsphere injection combined with FOLFIRI and bevacizumab as second-line therapy in patients with colorectal cancer liver metastases.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- SIRT with Yttrium-90 Microspheres, FOLFIRI and Bevacizumab
- Keywords
- Yttrium[90Y], colorectal cancer liver metastases, CRLM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIRT with Yttrium-90 MicrospheresDrug
Selective Internal Radiation Therapy (SIRT) with Yttrium-90 [90Y] Microspheres Injection
FOLFIRI and BevacizumabDrug
FOLFIRI and Bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| SIRT with Yttrium-90 Microspheres combined with FOLFIRI and Bevacizumab | Selective Internal Radiation Therapy (SIRT) with Yttrium-90 [90Y] Microspheres Injection combined with FOLFIRI and Bevacizumab Receives: Drug: SIRT with Yttrium-90 Microspheres; Drug: FOLFIRI and Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival(PFS)
Defined as the time from the start of FOLFIRI treatment to the date of radiographic progression or death due to any cause, whichever occurs first, based on RECIST 1.1 criteria.
Measured: until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
Secondary outcomes (6)
Objective response rate（ORR）
defined as the time between the date of initiation of treatment with FOLFIRI and the date of radiographic progression or death from any cause, whichever occurs first. According to RECIST 1.1 criteria.
Measured: until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
Disease control rate (DCR) for target lesions
defined as the proportion of subjects who achieve optimal tumor response or stable disease (complete response, partial response, or stable disease) over the course of the study. Assessed according to RECIST 1.1 criteria.
Measured: until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
Conversion resection rate
the proportion of participants who underwent successful surgical resection of unresectable CRLM after receiving SIRT in combination with FOLFIRI and bevacizumab.
Measured: until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
Hepatic progression-free survival (hPFS)
defined as the time between the date of initiation of treatment with FOLFIRI and the date of progression on liver imaging or death from any cause, whichever occurs first. Assessed according to RECIST 1.1 criteria.
Measured: until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
Overall survival (OS)
defined as the time between the date of initiation of treatment with FOLFIRI and the date of death due to any cause.
Measured: until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
Safety(adverse events)
Incidence of grade 3 and above adverse events (NCI-CTCAE v5.0) within 6 months from the start of SIRT treatment.
Measured: within 6 months from the start of SIRT treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start20 May 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies 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
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
- Investigators
- Gao-Jun Teng, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447727
- Sponsor's protocol ID
- ST-Y90-CP01
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of 90Y Microsphere Combined With FOLFIRI and Bevacizumab in Second-line Treatment of Colorectal Cancer Liver Metastasis
- ClinicalTrials.gov ID
- NCT06447727
- Acronym / sponsor ID
- ST-Y90-CP01
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- Yttrium[90Y], colorectal cancer liver metastases, CRLM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 7 Jun 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.
To observe the PFS of yttrium [90Y] microsphere injection combined with FOLFIRI and bevacizumab in second-line treatment of CRLM.
Detailed description
This study is a prospective, multicenter, observational, cohort study to observe the efficacy and safety of selective internal radiation therapy (SIRT) with yttrium [90Y] microsphere injection combined with FOLFIRI and bevacizumab as second-line therapy in patients with colorectal cancer liver metastases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIRT with Yttrium-90 Microspheres combined with FOLFIRI and Bevacizumab | – | Drug: SIRT with Yttrium-90 Microspheres, Drug: FOLFIRI and BevacizumabSelective Internal Radiation Therapy (SIRT) with Yttrium-90 [90Y] Microspheres Injection combined with FOLFIRI and Bevacizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with liver metastasis of colorectal cancer
Key inclusion criteria (9 listed)
- 18 years old≤ age ≤ 75 years old
- Voluntarily signed informed consent
- Patients with liver metastases of colorectal cancer, colorectal cancer lesions have resection, liver metastases limited to a single lobe
- The liver tumor progresses after first-line treatment, and FOLFIRI combined with bevacizumab therapy is planned
- On the assessment of the clinician, the patient was eligible for yttrium [90Y] microspheres injection, and treatment with yttrium [90Y] microspheres injection was planned
Key exclusion criteria (5 listed)
- After liver metastasis was diagnosed, the liver underwent external radiation therapy and transhepatic arterial chemoembolization
- Patients with extrahepatic metastases
- Pregnant and lactating women
- History of severe arrhythmia or heart failure
- Other researchers considered it inappropriate to participate in this 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 |
|---|---|---|
| SIRT with Yttrium-90 MicrospheresSelective Internal Radiation Therapy (SIRT) with Yttrium-90 [90Y] Microspheres Injection | Drug | SIRT with Yttrium-90 Microspheres combined with FOLFIRI and Bevacizumab |
| FOLFIRI and BevacizumabFOLFIRI and Bevacizumab | Drug | SIRT with Yttrium-90 Microspheres combined with FOLFIRI and Bevacizumab |
Primary outcome
Progression-Free Survival(PFS)
Time frame: until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
Defined as the time from the start of FOLFIRI treatment to the date of radiographic progression or death due to any cause, whichever occurs first, based on RECIST 1.1 criteria.
6 secondary outcomes
Objective response rate（ORR）
Time frame: until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
Disease control rate (DCR) for target lesions
Time frame: until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
Conversion resection rate
Time frame: until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
Hepatic progression-free survival (hPFS)
Time frame: until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
Overall survival (OS)
Time frame: until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.
Safety(adverse events)
Time frame: within 6 months from the start of SIRT treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
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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. This study is not recruiting at the moment.
Gao-Jun Teng principal investigator
Zhongda Hospital
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 Cancer Metastatic, run by Zhongda Hospital 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 9 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hai-Dong Zhu (+86-25-83272121, zhuhaidong9509@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival(PFS) (time frame: until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first.). 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 7 Jun 2024.