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

NCT07105631 | Recruiting

• 1 other identifier: CSIIT-Q108
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

HDAC inhibitors; pMMR/MSS; electronic patient-reported outcome; Real world study

Outcome Measures

Primary Outcomes (1)

• Grade 3-4 adverse effects rate

  Rate of HDACi and immunotherapy and others treatments related severe adverse events

  From date of randomization until the date of death from any cause, assessed up to 2 years]

Secondary Outcomes (5)

• Objective response rate（ORR）

  about a year

• Overall survival (OS)

  2 years

• Progression-free survival（PFS）

  2 years

• Duration of Response（DOR）

  2 years

• Clinical benefit rate （CBR）

  2 years

Study Arms (1)

Chidamide+Immune checkpoint inhibitors+others

Chidamide+Immune checkpoint inhibitors+others

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with MSS/pMMR advanced colorectal cancer treated with the Chidamide combined with ICI therapy regimen

You may qualify if:

• 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.

You may not qualify if:

• There are serious complications that interfere with the efficacy and safety analysis;

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital Sichuan University

Chengdu, Sichuan, 827153, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

meng Qiu PhD West China Hospital of Sichuan university

CONTACT

+8618980601776; mailtibet@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: August 6, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)