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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

S

Sichuan University

Status

Enrolling

Conditions

Colorectal Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT07105631
CSIIT-Q108

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

300 participants in 1 patient group

Chidamide+Immune checkpoint inhibitors+others
Description:
Chidamide+Immune checkpoint inhibitors+others

Trial contacts and locations

1

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Central trial contact

meng Qiu PhD West China Hospital of Sichuan university

Data sourced from clinicaltrials.gov

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