Colorectal CancerNCT07105631
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
An observational study of Colorectal Cancer, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2025to 30 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with MSS/pMMR advanced colorectal cancer treated with the Chidamide combined with ICI therapy regimen
Who may be able to join
- 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.
Who cannot join
- There are serious complications that interfere with the efficacy and safety analysis;
- The investigators determined that the subjects were not suitable for inclusion in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital Sichuan University
Chengdu, Sichuan, 827153
13551352412
About this study
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
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
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chidamide+Immune checkpoint inhibitors+others | Chidamide+Immune checkpoint inhibitors+others |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 3-4 adverse effects rate
Rate of HDACi and immunotherapy and others treatments related severe adverse events
Measured: From date of randomization until the date of death from any cause, assessed up to 2 years]
Secondary outcomes (5)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start10 Jul 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meng Qiu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105631
- Sponsor's protocol ID
- CSIIT-Q108
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07105631
- Acronym / sponsor ID
- CSIIT-Q108
- Conditions
- Colorectal Cancer
- Keywords
- HDAC inhibitors, pMMR/MSS, electronic patient-reported outcome, Real world study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidamide+Immune checkpoint inhibitors+others | – | –Chidamide+Immune checkpoint inhibitors+others |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with MSS/pMMR advanced colorectal cancer treated with the Chidamide combined with ICI therapy regimen
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- There are serious complications that interfere with the efficacy and safety analysis;
- The investigators determined that the subjects were not suitable for inclusion in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Grade 3-4 adverse effects rate
Time frame: From date of randomization until the date of death from any cause, assessed up to 2 years]
Rate of HDACi and immunotherapy and others treatments related severe adverse events
5 secondary outcomes
Objective response rate（ORR）
Time frame: about a year
Overall survival (OS)
Time frame: 2 years
Progression-free survival（PFS）
Time frame: 2 years
Duration of Response（DOR）
Time frame: 2 years
Clinical benefit rate （CBR）
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact meng Qiu PhD West China Hospital of Sichuan university (+8618980601776, mailtibet@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade 3-4 adverse effects rate (time frame: From date of randomization until the date of death from any cause, assessed up to 2 years]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.