Patient-reported and clinical outcomes after Chidamide plus sintilimab (± bevacizumab) for MSS advanced colorectal cancer
Official 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
Run by West China Hospital · NCT07105631 · Data updated 2026-11-12
This project will see how well Chidamide combined with sintilimab, with or without bevacizumab, is tolerated and reported by Chinese adults with MSS advanced colorectal cancer receiving it in routine care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | West China Hospital Academic / other |
| Drugs / interventions | sintilimab, bevacizumab, sidibemab |
| Locations | 1 site (Chengdu, Sichuan) |
| Status | Recruiting |
| Started | July 10, 2025 |
| Main results expected | July 30, 2026 |
| Study ends | July 30, 2027 |
| Registry record updated | August 6, 2025 |
| Trial ID | NCT07105631 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) with histologically confirmed advanced MSS/pMMR colorectal cancer whom their treating physician plans to treat with an HDAC inhibitor plus immune checkpoint inhibitor regimen and who can use a smartphone for electronic reporting.
✕Probably not a fit
Patients with serious uncontrolled comorbidities, those judged unsuitable by investigators, those who cannot use an internet-capable mobile device, or those with non‑MSS tumor types are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective real-world observational cohort enrolling adults with histologically confirmed MSS/pMMR advanced colorectal cancer treated with an HDAC inhibitor plus an immune checkpoint inhibitor regimen. Participants report symptoms and quality-of-life measures electronically while clinicians record safety events and treatment outcomes. The primary endpoint is safety events related to the combination regimen; secondary data include patient-reported outcomes and clinical effectiveness in routine practice. Enrollment and follow-up occur at West China Hospital, and no specific investigational treatment is assigned by the protocol.
Why it matters
Potential benefit: If successful, the project will clarify real-world safety and patient-experienced side effects to help clinicians and patients make informed treatment decisions about this combination regimen.
How similar studies have gone: Small trials such as the phase II CAPability-01 and guideline inclusion have suggested promise for similar combinations, but large prospective real-world data remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
West China Hospital Sichuan University
Chengdu, Sichuan, China Recruiting
Study contacts
- Study coordinator: meng Qiu PhD West China Hospital of Sichuan university
- Email: mailtibet@yahoo.com
- Phone: +8618980601776
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.