Colorectal Cancer
Conditions
Keywords
HDAC inhibitors, pMMR/MSS, electronic patient-reported outcome, Real world study
Brief summary
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.
Interventions
None listed
Sponsors
West China Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old, gender not restricted; 2. Advanced colorectal cancer confirmed by histopathology; and confirmed as MSS/pMMR type by immunohistochemistry or genetic testing; 3. The investigators evaluate that the treatment regimen of cediranib combined with immune checkpoint inhibitors is applicable; 4. Clear consciousness, able to answer questions correctly; 5. Capable of using mobile phones and accessing the internet, with 3G/4G/5G function of smart mobile devices.
Exclusion criteria
1. There are serious complications that interfere with the efficacy and safety analysis; 2. The investigators determined that the subjects were not suitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grade 3-4 adverse effects rate | From date of randomization until the date of death from any cause, assessed up to 2 years] | Rate of HDACi and immunotherapy and others treatments related severe adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate（ORR） | about a year | Objective response is defined as a complete response (CR ) or partial response (PR) according to RECIST v.1.1 or iRECIST |
| Overall survival (OS) | 2 years | 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. |
| Progression-free survival（PFS） | 2 years | 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. |
| Duration of Response（DOR） | 2 years | 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. |
| Clinical benefit rate （CBR） | 2 years | 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. |
Countries
China
Contacts
Primary Contactmeng Qiu PhD West China Hospital of Sichuan university
Outcome results
None listed