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NCT Number: NCT07105631

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

West China Hospital Sichuan University

Chengdu, Sichuan, 827153, China

Location status: Recruiting

Location contact

CONTACT

13551352412

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Objective response rate（ORR）

    Time frame: about a year

    Objective response is defined as a complete response (CR

    ) or partial response (PR) according to RECIST v.1.1 or iRECIST

  2. Overall survival (OS)

    Time frame: 2 years

    Time from randomization to date of death due to any cause

    . according to the RECIST version 1.1 or iRecist recorded in the time period between randomization death to any cause.

  3. Progression-free survival（PFS）

    Time frame: 2 years

    Time from randomization to date of Disease progression or death due to any cause.according to the RECIST version 1.1 or iRecist recorded in the time period between randomization and disease progression or death to any cause.

  4. Duration of Response（DOR）

    Time frame: 2 years

    Time from randomization to date of the first assessment of the tumor as CR (Complete Response) or PR (Partial Response) until the first assessment of PD (Progressive Disease) or death for any reason.according to the RECIST version 1.1 or iRecist.

  5. Clinical benefit rate （CBR）

    Time frame: 2 years

    Time from randomization to date of the first assessment of the tumor as CR (Complete Response) or PR (Partial Response) or SD (Stable Disease)rate.according to the RECIST version 1.1 or iRecist.

Study contacts

Contact information is provided by the study sponsor or research team.

meng Qiu PhD West China Hospital of Sichuan university

CONTACT

[email protected]

+8618980601776

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 6, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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