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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: meng Qiu PhD West China Hospital of Sichuan university; Phone Number: +8618980601776; Email: mailtibet@yahoo.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 827153
      • Recruiting
      • West China Hospital Sichuan University
      • Contact: Phone Number: 13551352412

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Chidamide+Immune checkpoint inhibitors+others

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate（ORR）	Objective response is defined as a complete response (CR ) or partial response (PR) according to RECIST v.1.1 or iRECIST	about a year
Overall survival (OS)	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.	2 years
Progression-free survival（PFS）	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.	2 years
Duration of Response（DOR）	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.	2 years
Clinical benefit rate （CBR）	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.	2 years

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: May 20, 2025
• First Submitted That Met QC Criteria: August 5, 2025
• First Posted (Actual): August 6, 2025

Study Record Updates

• Last Update Posted (Actual): August 6, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: HDAC inhibitors; Real world study; pMMR/MSS; electronic patient-reported outcome
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CSIIT-Q108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No