Colorectal Cancer MetastaticNCT06682247
A Real-world Study of Chidamide in Combination with PD-1/PD-L1 Antibodies and Anti-angiogenic Agents in Advanced MSS Colorectal Cancer
An observational study of Colorectal Cancer Metastatic, run by Feng Wang.
Trial summary
This is an observational , multicenter, real-world study aimed at evaluating the efficacy and safety of the combination of immune checkpoint inhibitors, chidamide and antiangiogenic agents in Microsatellite Stable advanced colorectal cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- Chidamide, Tucidinostat; PD-1/PD-L1 inhibitor or double antibodies; Bevacizumab or tyrosine kinase inhibitors
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2024to 31 Dec 2025
- 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: advanced/metastatic MSS colorectal cancer patients
Who may be able to join
- Aged≥18 years
- Histology-confirmed metastatic CRC (mCRC);
- ECOG 0~2
- At least one efficacy evaluation
- Life expectancy of at least 3 months.
Who cannot join
- Lack of follow-up data.
- Chidamide stopped after less than two cycles.
- Serious comorbidities that interfere with the efficacy or safety analysis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Real-world Study of Chidamide in Combination with PD-1/PD-L1 Antibodies and Anti-angiogenic Agents in the Treatment of Microsatellite Stable Advanced Colorectal Cancer
This is an observational , multicenter, real-world study aimed at evaluating the efficacy and safety of the combination of immune checkpoint inhibitors, chidamide and antiangiogenic agents in Microsatellite Stable advanced colorectal cancer patients.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- Chidamide, Tucidinostat; PD-1/PD-L1 inhibitor or double antibodies; Bevacizumab or tyrosine kinase inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chidamide, Tucidinostat; PD-1/PD-L1 inhibitor or double antibodies; Bevacizumab or tyrosine kinase inhibitorsDrug
Chidamide, Tucidinostat; PD-1/PD-L1 inhibitor or double antibodies; Bevacizumab or tyrosine kinase inhibitors
| Study group | Role | What they receive |
|---|---|---|
| chidamide + PD-1/PD-L1 inhibitors +Bevacizumab or tyrosine kinase inhibitors | Not described Receives: Drug: Chidamide, Tucidinostat; PD-1/PD-L1 inhibitor or double antibodies; Bevacizumab or tyrosine kinase inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival(PFS)
Measured: 2 years
Secondary outcomes (4)
Objective Response Rate（ORR）
Measured: 2 years
Clinical Benefit Rate (CBR)
Measured: 2 years
Disease Control Rate （DCR）
Measured: 2 years
Overall survival (OS)
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 posted12 Nov 2024
- Study start15 Nov 2024 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Feng Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Feng Wang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06682247
- Sponsor's protocol ID
- CSIIT-Q88
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of Chidamide in Combination with PD-1/PD-L1 Antibodies and Anti-angiogenic Agents in the Treatment of Microsatellite Stable Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06682247
- Acronym / sponsor ID
- CSIIT-Q88
- Conditions
- Colorectal Cancer Metastatic
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Feng WangUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Nov 2024 (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.
This is an observational , multicenter, real-world study aimed at evaluating the efficacy and safety of the combination of immune checkpoint inhibitors, chidamide and antiangiogenic agents in Microsatellite Stable advanced colorectal cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chidamide + PD-1/PD-L1 inhibitors +Bevacizumab or tyrosine kinase inhibitors | – | Drug: Chidamide, Tucidinostat; PD-1/PD-L1 inhibitor or double antibodies; Bevacizumab or tyrosine kinase inhibitors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- advanced/metastatic MSS colorectal cancer patients
Key inclusion criteria (5 listed)
- Aged≥18 years
- Histology-confirmed metastatic CRC (mCRC);
- ECOG 0~2
- At least one efficacy evaluation
- Life expectancy of at least 3 months.
Key exclusion criteria (3 listed)
- Lack of follow-up data.
- Chidamide stopped after less than two cycles.
- Serious comorbidities that interfere with the efficacy or safety analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chidamide, Tucidinostat; PD-1/PD-L1 inhibitor or double antibodies; Bevacizumab or tyrosine kinase inhibitorsChidamide, Tucidinostat; PD-1/PD-L1 inhibitor or double antibodies; Bevacizumab or tyrosine kinase inhibitors | Drug | chidamide + PD-1/PD-L1 inhibitors +Bevacizumab or tyrosine kinase inhibitors |
Primary outcome
Progression-free survival(PFS)
Time frame: 2 years
4 secondary outcomes
Objective Response Rate（ORR）
Time frame: 2 years
Clinical Benefit Rate (CBR)
Time frame: 2 years
Disease Control Rate （DCR）
Time frame: 2 years
Overall survival (OS)
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 12 Nov 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Metastatic, run by Feng Wang.
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 3 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: opening soon, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 feng wang (020-87343088, wangfeng@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival(PFS) (time frame: 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 12 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.