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The Chidamide + sintilimab ± bevacizumab regimen has become a post-treatment option for clinicians and patients after being included in the guidelines. The CAPability-01 study is a phase II RCT, with a limited number of enrolled subjects. Further observation of the safety and clinical real-world application status of the sidibemab combination regimen is needed in a larger sample size prospective observational cohort study. The primary endpoint of this study is the safety events of the sidibemab combination regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chidamide+Immune checkpoint inhibitors+others | Chidamide+Immune checkpoint inhibitors+others |
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| Measure | Description | Time Frame |
|---|---|---|
| Grade 3-4 adverse effects rate | Rate of HDACi and immunotherapy and others treatments related severe adverse events | From date of randomization until the date of death from any cause, assessed up to 2 years] |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR) | Objective response is defined as a complete response (CR ) or partial response (PR) according to RECIST v.1.1 or iRECIST | about a year |
| Overall survival (OS) | Time from randomization to date of death due to any cause . according to the RECIST version 1.1 or iRecist recorded in the time period between randomization death to any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with MSS/pMMR advanced colorectal cancer treated with the Chidamide combined with ICI therapy regimen
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| meng Qiu PhD West China Hospital of Sichuan university | Contact | +8618980601776 | mailtibet@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital Sichuan University | Recruiting | Chengdu | Sichuan | 827153 | China |
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| 2 years |
| Progression-free survival(PFS) | Time from randomization to date of Disease progression or death due to any cause.according to the RECIST version 1.1 or iRecist recorded in the time period between randomization and disease progression or death to any cause. | 2 years |
| Duration of Response(DOR) | Time from randomization to date of the first assessment of the tumor as CR (Complete Response) or PR (Partial Response) until the first assessment of PD (Progressive Disease) or death for any reason.according to the RECIST version 1.1 or iRecist. | 2 years |
| Clinical benefit rate (CBR) | Time from randomization to date of the first assessment of the tumor as CR (Complete Response) or PR (Partial Response) or SD (Stable Disease)rate.according to the RECIST version 1.1 or iRecist. | 2 years |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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