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

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

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.

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.