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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Primary outcome measures
- 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]]
Secondary outcome measures (5)
- Objective response rate（ORR） [Time frame: about a year]
- Overall survival (OS) [Time frame: 2 years]
- Progression-free survival（PFS） [Time frame: 2 years]
- Duration of Response（DOR） [Time frame: 2 years]
- Clinical benefit rate （CBR） [Time frame: 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- West China Hospital Sichuan University — Chengdu
Identifiers
NCT: NCT07105631 · CSIIT-Q108