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To observe the PFS of yttrium [90Y] microsphere injection combined with FOLFIRI and bevacizumab in second-line treatment of CRLM.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIRT with Yttrium-90 Microspheres | Drug | Selective Internal Radiation Therapy (SIRT) with Yttrium-90 [90Y] Microspheres Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | until death or 18 months after treatment with yttrium [90Y] microspheres, whichever occurred first. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with liver metastasis of colorectal cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hai-Dong Zhu | Contact | +86-25-83272121 | zhuhaidong9509@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Gao-Jun Teng | Zhongda Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital,Southeast University | Recruiting | Nanjing | Jiangsu | 210009 | China |
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| ID | Term |
|---|---|
| D037761 | Sirtuins |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D056545 | Group III Histone Deacetylases |
| D006655 | Histone Deacetylases |
| D000581 | Amidohydrolases |
| D006867 | Hydrolases |
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| FOLFIRI and Bevacizumab | Drug | FOLFIRI and Bevacizumab |
|
| 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. |
| 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. | 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. | 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. | 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. | within 6 months from the start of SIRT treatment. |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D036002 | ADP Ribose Transferases |
| D010430 | Pentosyltransferases |
| D016695 | Glycosyltransferases |
| D014166 | Transferases |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |