Colorectal CancerPhase 3NCT06497985
A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients
A Phase 3 study testing Tucidinostat, Sintilimab and Bevacizumab in people with Colorectal Cancer, run by Chipscreen Biosciences, Ltd. at 1 site in China.
Trial summary
A randomised, open-label, multicenter phase III study to evaluate the efficacy and safety of tucidinostat in combination with sintilimab and bevacizumab versus fruquintinib monotherapy in MSS/pMMR colorectal cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Tucidinostat, Sintilimab and Bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2024to 30 Sep 2028
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent for the study.
- Age ≥18 years and ≤75 years.
- Histologically or cytologically confirmed unresectable and metastatic colorectal adenocarcinoma.
- Has been previously treated and has shown disease progression or could not tolerate standard treatment, which must include fluoropyrimidine, irinotecan and oxaliplatin, with or without an anti-vascular endothelial growth factor (VEGF) monoclonal antibody (bevacizumab) or anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (cetuximab or panitumumab) .
- Have confirmed MSS or MSI-L, or pMMR.
- KRAS status must have been previously determined (mutant or wild-type) .
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- Measurable disease per RECIST v1.1.
- ECOG PS 0 or 1.
- Adequate organ function.
- Expected survival >12 weeks.
Who cannot join
- Prior use of HDAC inhibitor.
- Received prior therapies targeting PD-1, PD-L1, CTLA4, or any other immune checkpoint pathway.
- Prior use of small-molecule tyrosine kinase inhibitor of VEGF receptors.
- Received any anti-tumor therapy or investigational agent and device within 28 days before the first dose of study treatment.
- Received radiotherapy within 28 days before the first dose of study treatment.
- If randomized into the control group, it is planned to use the combination of tucidinostat with PD-1 inhibitor and bevacizumab after the end of study treatment.
Show all 35Show fewer
- History of autoimmune diseases requiring systemic treatment within 2 years before the first dose of study treatment.
- Known history of primary immunodeficiency.
- Received systemic immunosuppressive drugs within 28 days before the first dose of study treatment.
- Received systemic immunostimulatory drugs within 28 days before the first dose of study treatment.
- Received major surgery within 28 days before the first dose of study treatment.
- Received a live vaccine within 28 days before the first dose of study treatment or planned to receive during the study period.
- Has not recovered ( ≤ Grade 1 defined by CTCAE V5.0) from AEs due to prior anti-cancer therapy.
- Has uncontrolled diabetes assessed by investigators within 7 days before the first dose of study treatment.
- Has symptomatic and untreated central nervous system (CNS) metastases.
- Has uncontrollable or major cardiovascular disease.
- History of cerebrovascular accidents within 6 months before the first dose of study treatment.
- History of serious thromboembolism within 6 months before the first dose of study treatment.
- History of gastrointestinal perforation and/or fistula etc., within 6 months before the first dose of study treatment.
- Obvious gastrointestinal abnormalities during the screening period,which may affect the intake, transport or absorption of drugs.
- Known history of bleeding disorders or coagulopathy.
- Anticoagulants or thrombolytic agents are being used during the screening period.
- Uncontrolled pleural/abdominal/pericardial effusion that was drained within 14 days before the first dose of study treatment.
- Suspected interstitial lung disease (ILD) or pulmonary fibrosis or pulmonary inflammation requiring treatment.
- Severe or active infection requiring systemic therapy.
- Known active pulmonary tuberculosis.
- Active hepatitis B or hepatitis C.
- HIV positive or syphilis infection.
- History of malignant tumor.
- History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- History of hypersensitivity to study drugs, or any of its excipients.
- History of alcohol or drug abuse.
- Unwilling or unable to comply with procedures required in this protocol.
- Pregnant or breast-feeding women. Male/Female is unwilling or unable to use a highly effective method of birth control.
- Any condition not suitable for participating in the trial in the opinion of the Investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rui-Hua Xu contact
China1 site, 1 recruiting
- Recruiting
Rui-Hua Xu
Guangzhou, Guangdong, 510050
Ran Xu, 020-87343565, xuran@sysucc.org.cn
About this study
Official title: A Randomised, Open-label, Multicenter Phase III Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients Who Failed at Least Second-line Standard Therapies
A randomised, open-label, multicenter phase III study to evaluate the efficacy and safety of tucidinostat in combination with sintilimab and bevacizumab versus fruquintinib monotherapy in MSS/pMMR colorectal cancer patients.
Read the detailed description
This is a randomised, open-label, multicenter phase III study evaluating the efficacy and safety of tucidinostat in combination with sintilimab and bevacizumab versus fruquintinib monotherapy in MSS/pMMR colorectal cancer patients. 430 patients will be randomised (1:1) to receive tucidinostat in combination with sintilimab and bevacizumab (experimental arm) or fruquintinib monotherapy (control arm).
- Conditions
- Colorectal Cancer
- Being tested
- Tucidinostat, Sintilimab, Bevacizumab, Fruquintinib
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TucidinostatDrug
Also called Chidamide
30mg orally BIW
SintilimabDrug
200 mg intravenously (IV) Q3W
BevacizumabDrug
7.5mg/kg intravenously (IV) Q3W
FruquintinibDrug
5mg orally QD
| Study group | Role | What they receive |
|---|---|---|
| tucidinostat+sintilimab+bevacizumab | Experimental | Not described Receives: Drug: Tucidinostat; Drug: Sintilimab; Drug: Bevacizumab |
| fruquintinib | Active comparator | Not described Receives: Drug: Fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
From randomization to the date of death from any cause.
Measured: Up to approximately 2 years
Secondary outcomes (9)
Progression Free Survival (PFS)
PFS assessed by investigator per RECIST v1.1, measured from the date of randomization until progression or death, whichever occurs first.
Measured: Up to approximately 2 years
Overall response rate (ORR)
Proportion of participants who achieved complete response (CR) or partial response (PR) assessed by investigator according to RECIST v1.1.
Measured: Up to approximately 2 years
Duration of response (DOR)
From the first occurrence of PR or CR until the date of first documented progression according to RECIST 1.1, or death, whichever occurs first.
Measured: Up to approximately 2 years
Disease control rate (DCR)
Proportion of participants who achieved CR or PR, or stable disease (SD) assessed by investigator according to RECIST v1.1.
Measured: Up to approximately 2 years
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life Scale Score
EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and global health status/QOL scale.Change from baseline in the EORTC QLQ-C30 Global Health Status/Quality of Life Scale scores will be presented.
Measured: Up to approximately 2 years
Change From Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Health Utility Index Scores
The EQ-5D-5L is a self-reported health status questionnaire that consisted of 2 components: health state profile and optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: no problem, slight problem, moderate problem, severe problem, and extreme problem. Change from baseline in health utility index scores will be presented.
Measured: Up to approximately 2 years
Change From Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score
EQ-5D-5L consisted of 2 components: health state profile and optional VAS. The VAS records the respondent's self-rated health on a vertical visual analogue scale. The VAS 'thermometer' has endpoints of 100 (Best imaginable health state) at the top and 0 (Worst imaginable health state) at the bottom. Change from baseline in EQ-5D-5L VAS scores will be presented.
Measured: Up to approximately 2 years
Safety and Tolerability
Number of Participants Who Experience an Adverse Event (AE) assessed by CTCAE v5.0.
Measured: Up to approximately 2 years
Plasma concentrations of tucidinostat
Plasma samples were collected from the participants at the defined time points. Plasma concentrations were measured using a validated, specific, and sensitive method.
Measured: Up to approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start6 Dec 2024
- Primary completion31 May 2028 (estimated)
- Study completion30 Sep 2028 (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 Chipscreen Biosciences, Ltd.The 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chipscreen Biosciences, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rui-Hua Xu, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497985
- Sponsor's protocol ID
- CDM303
- Status last verified
- Mar 2026
- First submitted
- 28 Jun 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open-label, Multicenter Phase III Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients Who Failed at Least Second-line Standard Therapies
- ClinicalTrials.gov ID
- NCT06497985
- Acronym / sponsor ID
- CDM303
- Conditions
- Colorectal Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Chipscreen Biosciences, Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 12 Jul 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.
A randomised, open-label, multicenter phase III study to evaluate the efficacy and safety of tucidinostat in combination with sintilimab and bevacizumab versus fruquintinib monotherapy in MSS/pMMR colorectal cancer patients.
Detailed description
This is a randomised, open-label, multicenter phase III study evaluating the efficacy and safety of tucidinostat in combination with sintilimab and bevacizumab versus fruquintinib monotherapy in MSS/pMMR colorectal cancer patients. 430 patients will be randomised (1:1) to receive tucidinostat in combination with sintilimab and bevacizumab (experimental arm) or fruquintinib monotherapy (control arm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tucidinostat+sintilimab+bevacizumab | Experimental | Drug: Tucidinostat, Drug: Sintilimab, Drug: Bevacizumab |
| fruquintinib | Active comparator | Drug: Fruquintinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provide written informed consent for the study.
- Age ≥18 years and ≤75 years.
- Histologically or cytologically confirmed unresectable and metastatic colorectal adenocarcinoma.
- Has been previously treated and has shown disease progression or could not tolerate standard treatment, which must include fluoropyrimidine, irinotecan and oxaliplatin, with or without an anti-vascular endothelial growth factor (VEGF) monoclonal antibody (bevacizumab) or anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (cetuximab or panitumumab) .
- Have confirmed MSS or MSI-L, or pMMR.
Key exclusion criteria (35 listed)
- Prior use of HDAC inhibitor.
- Received prior therapies targeting PD-1, PD-L1, CTLA4, or any other immune checkpoint pathway.
- Prior use of small-molecule tyrosine kinase inhibitor of VEGF receptors.
- Received any anti-tumor therapy or investigational agent and device within 28 days before the first dose of study treatment.
- Received radiotherapy within 28 days before the first dose of study treatment.
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 |
|---|---|---|
| TucidinostatAlso: Chidamide30mg orally BIW | Drug | tucidinostat+sintilimab+bevacizumab |
| Sintilimab200 mg intravenously (IV) Q3W | Drug | tucidinostat+sintilimab+bevacizumab |
| Bevacizumab7.5mg/kg intravenously (IV) Q3W | Drug | tucidinostat+sintilimab+bevacizumab |
| Fruquintinib5mg orally QD | Drug | fruquintinib |
Primary outcome
Overall Survival (OS)
Time frame: Up to approximately 2 years
From randomization to the date of death from any cause.
9 secondary outcomes
Progression Free Survival (PFS)
Time frame: Up to approximately 2 years
Overall response rate (ORR)
Time frame: Up to approximately 2 years
Duration of response (DOR)
Time frame: Up to approximately 2 years
Disease control rate (DCR)
Time frame: Up to approximately 2 years
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life Scale Score
Time frame: Up to approximately 2 years
Change From Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Health Utility Index Scores
Time frame: Up to approximately 2 years
Change From Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score
Time frame: Up to approximately 2 years
Safety and Tolerability
Time frame: Up to approximately 2 years
Plasma concentrations of tucidinostat
Time frame: Up to approximately 6 months
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 19 Mar 2026.
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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.
Rui-Hua Xu contact
Rui-Hua Xu principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tucidinostat, Sintilimab and Bevacizumab in people with Colorectal Cancer, run by Chipscreen Biosciences, Ltd. 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 10 inclusion and 35 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 19 Mar 2026. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xinhao Wang (+86 0755-36993550, xinhwang@chipscreen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to approximately 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 19 Mar 2026.