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

NCT ID: NCT07105631

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-10

Study Completion Date

2027-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Chidamide+Immune checkpoint inhibitors+others

Chidamide+Immune checkpoint inhibitors+others

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Meng Qiu

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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West China Hospital Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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meng Qiu PhD West China Hospital of Sichuan university

Role: CONTACT

+8618980601776

Facility Contacts

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Role: primary

13551352412

Other Identifiers

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CSIIT-Q108

Identifier Type: -

Identifier Source: org_study_id

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