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| Name | Class |
|---|---|
| Shanghai Shengdi Pharmaceutical Co., Ltd | INDUSTRY |
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The goal of this clinical trial is to learn about Fruquintinib combined with Adebrelimab and high and low dose radiotherapy in the treatment of second-line and above failure MSS(microsatellite stability) metastatic colorectal cancer.
The main question it aims to answer is: The efficacy and safety of Fruquintinib combined with Adebrelimab and high and low dose radiotherapy in the third line and beyond treatment of MSS metastatic colorectal cancer.
Participants will receive the combination of Fruquintinib and Adebrelimab within 3 weeks after completion of high and low dose radiotherapy on metastases until disease progression or intolerable toxicity occurred.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fruquintinib Group | Experimental | Participants will receive the combination of Fruquintinib and Adebrelimab within 3 weeks after completion of high and low dose radiotherapy on metastases until disease progression or intolerable toxicity occurred. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fruquintinib | Drug | After receiving high and low dose radiotherapy on metastases, the enrolled patients will receive the combination of Fruquintinib and Adebrelimab. RECIST 1.1 standard was used for clinical tumor imaging evaluation every 6 weeks (±7 days). For complete response (CR) ,partial response (PR), or stable disease (SD), the enrolled patients will continue to receive the combination of Fruquintinib and Adebrelimab. Participants will receive the combination of Fruquintinib and Adebrelimab until disease progression or intolerable toxicity occurred. |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | objective response rate | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression Free Survival | 2 years |
| OS | Overall Survival | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaitai Liu, doctor | Contact | +8613732112205 | liukaitai@nbu.edu.cn | |
| Shuang Ye, master | Contact | +8615867883987 | yeshuang2713@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaitai Liu | Recruiting | Ningbo | Zhejiang | 315040 | China |
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| DCR |
Disease Control Rate |
| 3 years |
| DoR | Duration of Overall Response | 3 years |
| AE | adverse event | 3 years |
| ID | Term |
|---|---|
| C000591844 | HMPL-013 |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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