Patient-reported Outcomes (PRO) and Treatment Outcomes of Chinese Patients With MSS-type Advanced Colorectal Cancer Who Received the Zidovudine Combination Regimen in the Real World: A Prospective, Multicenter, Observational Study Protocol
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- West China Hospital
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Grade 3-4 adverse effects rate
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years old, gender not restricted;
- •Advanced colorectal cancer confirmed by histopathology; and confirmed as MSS/pMMR type by immunohistochemistry or genetic testing;
- •The investigators evaluate that the treatment regimen of cediranib combined with immune checkpoint inhibitors is applicable;
- •Clear consciousness, able to answer questions correctly;
- •Capable of using mobile phones and accessing the internet, with 3G/4G/5G function of smart mobile devices.
Exclusion Criteria
- •There are serious complications that interfere with the efficacy and safety analysis;
- •The investigators determined that the subjects were not suitable for inclusion in this study.
Outcomes
Primary Outcomes
Grade 3-4 adverse effects rate
Time Frame: 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 Outcomes
- Objective response rate（ORR）(about a year)
- Overall survival (OS)(2 years)
- Progression-free survival（PFS）(2 years)
- Duration of Response（DOR）(2 years)
- Clinical benefit rate （CBR）(2 years)
Investigators
Meng Qiu
PhD
West China Hospital