Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Chidamide+Immune checkpoint inhibitors+others
- description
- Chidamide+Immune checkpoint inhibitors+others
Primary outcomes (1)
- measure
- Grade 3-4 adverse effects rate
- timeFrame
- From date of randomization until the date of death from any cause, assessed up to 2 years]
- description
- Rate of HDACi and immunotherapy and others treatments related severe adverse events
Secondary outcomes (5)
- measure
- Objective response rate（ORR）
- timeFrame
- about a year
- description
- Objective response is defined as a complete response (CR ) or partial response (PR) according to RECIST v.1.1 or iRECIST
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available