Patient-reported and clinical outcomes after Chidamide plus sintilimab (± bevacizumab) for MSS advanced colorectal cancer
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
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | West China Hospital Academic / other |
| Drugs / interventions | sintilimab, bevacizumab, sidibemab |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT07105631 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Chengdu, Sichuan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.