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Clinical Trials/NCT07105631
NCT07105631RecruitingNot Applicable

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

West China Hospital1 site in 1 country300 target enrollmentStarted: July 10, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Meng Qiu

PhD

West China Hospital

Study Sites (1)

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