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This study is a multicentre, prospective, randomised trial, aims to evaluate the efficacy and safety of Irinotecan Drug-Eluting Beads combined with regorafenib as the third-line treatment for a patient with colorectal cancer liver metastases. The study is planned to enrolled 126 patients failing first- and second-line standard chemotherapy treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irinotecan Drug-Eluting Beads combined with regorafenib | Experimental |
| |
| regorafenib | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regorafenib and DIBIRI | Drug | Drug: Regorafenib Regorafenib will be given 3 weeks on/1 week off (initial dose: 80 mg od po.) Drug: Irinotecan it will be mixed in eluting-beads and injected in the tumor. Procedure: TACE Transcatheter arterial chemoembolization(TACE)is a minimally invasive procedure performed to decrease the tumor's blood supply. Device: drug eluting-bead The eluting-bead,loaded with irinotecan (DEBIRI) to treat patients with hepatic metastases from colorectal cancer. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | The PFS is defined as the time from the start of treatment to the date of first documented PD or death as a result of any cause, whichever occurred first. When a patient was alive and without progression, PFS was censored at the date of the last disease assessment. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo Zhang, M.D | Contact | 86-13660397903 | zhangb28@mail.sysu.edu.cn | |
| Bo Zhang, M.D | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bo Zhang, M.D | Sixth Affiliated Hospital, Sun Yat-sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bo Zhang | Recruiting | Guangdong | Guangzhou | China |
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| ID | Term |
|---|---|
| C559147 | regorafenib |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Regorafenib | Drug | Drug: Regorafenib Regorafenib will be given 3 weeks on/1 week off (initial dose: 80 mg od po.) |
|
| Objective Response Rate (ORR) |
The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR) |
| 24 months |
| Disease Control Rate (DCR) | DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating) | 24 months |
| Duration of response (DOR) | It was defined as the time from the first judgment of complete remission (CR) or partial remission (PR) to the discovery of disease progression (PD) after treatment | 24 months |
| Adverse enents | Safety variables will be summarized using descriptive statistics based on adverse events collection | 24 months |