Metastatic Colorectal CancerPhase 2NCT06858969
Chidamide in Combination With PD-1 Inhibitor, Bevacizumab, and XELOX for Metastatic Colorectal Cancer
A Phase 2 study testing Treatment group in people with Metastatic Colorectal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial summary
This phase II, open-label, dose-escalation study aims to (1) assess the safety and tolerability of chidamide in combination with PD-1 inhibitor, bevacizumab, and XELOX as first-line therapy for treatment-naïve metastatic colorectal cancer patients, (2) establish the recommended phase II dose (RP2D) of the combination… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Treatment group
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 9 Apr 2025to 8 Jan 2028
- Phase
- Phase 2
- 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
- Age ≥18 years and ≤75 years, regardless of gender; Histologically confirmed unresectable metastatic/recurrent colorectal adenocarcinoma; No prior systemic antitumor therapy received for metastatic/recurrent colorectal adenocarcinoma; For subjects who have received prior neoadjuvant/adjuvant therapy, the interval between the last treatment and recurrence/progression must exceed 12 months; ECOG performance status 0-1; At least one measurable lesion (per RECIST v1.1 criteria); Expected survival ≥3 months;
- Organ function must meet the following requirements prior to the first dose of the investigational drug:
- Hematological function (no blood transfusion or growth factor administration within 14 days before screening):
- Absolute neutrophil count ≥1.5×10^9/L, Platelet count ≥100×10^9/L, Hemoglobin ≥90 g/L;
- Hepatic and renal function (no albumin infusion within 14 days before screening):
- Total bilirubin ≤1.5×ULN, Serum albumin ≥25 g/L, ALT and AST ≤2.5×ULN (≤5.0×ULN for patients with liver metastases), Serum creatinine ≤1.5×ULN;
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- Coagulation function:
- INR ≤1.5×ULN, PT and APTT ≤1.5×ULN;
- Urinalysis:
- Urine protein <2+; for subjects with baseline urine protein ≥2+, 24-hour urine protein quantification must be <1 g; Subjects (including females and males) must agree to use effective contraception from signing the informed consent form until 180 days after the last dose of the investigational drug. Females of childbearing potential must not be pregnant or breastfeeding; Prior treatment-related adverse events (AEs) must have resolved to ≤Grade 1 (per NCI CTCAE v5.0, except alopecia); Voluntary participation in this clinical trial with written informed consent.
Who cannot join
- Subjects with known tumor microsatellite instability-high (MSI-H) status.
- Prior treatment with histone deacetylase (HDAC) inhibitors, including but not limited to chidamide or entinostat.
- Prior postoperative adjuvant therapy targeting EGFR or VEGF/VEGFR, including bevacizumab, cetuximab, panitumumab, aflibercept, regorafenib, or biosimilars of these agents.
- Prior treatment with T-cell co-stimulation or immune checkpoint therapies, including CTLA-4 inhibitors, PD-1/PD-L1/PD-L2 inhibitors, or other T-cell-targeted drugs.
- Active hepatitis B (HBV DNA ≥ 500 IU/mL) or hepatitis C (HCV antibody-positive with HCV-RNA above the lower limit of detection).
- Central nervous system (CNS) metastases or leptomeningeal metastases.
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- History of cerebrovascular accident, myocardial infarction, unstable angina, or poorly controlled arrhythmia within the past 6 months (including QTc interval ≥ 450 ms in males or ≥ 470 ms in females, calculated via Fridericia's formula).
- Clinically uncontrolled pleural effusion, ascites, or pericardial effusion requiring intervention and deemed ineligible by the investigator.
- Cardiac dysfunction (NYHA class III/IV) or left ventricular ejection fraction (LVEF) < 50% on echocardiography.
- History of other malignancies within 5 years prior to signing informed consent, except cured basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ.
- Immunodeficiency, including HIV positivity, congenital/acquired immune deficiency, or history of organ/allogeneic bone marrow transplantation.
- Active autoimmune disease or autoimmune disease history (e.g., interstitial pneumonia, colitis, hepatitis, thyroid dysfunction). Exceptions: vitiligo, childhood asthma/allergies in remission without adult intervention, stable hypothyroidism on hormone replacement, or type I diabetes on stable insulin.
- Uncontrolled hypertension (systolic ≥ 150 mmHg and/or diastolic ≥ 100 mmHg).
- History of hypertensive crisis or hypertensive encephalopathy.
- Systemic corticosteroid use (>10 mg prednisone daily or equivalent) or immunosuppressants within 2 weeks prior to treatment.
- Active systemic infection requiring IV antibiotics >7 days within 2 weeks prior to treatment.
- Anti-tuberculosis therapy within 1 year prior to treatment.
- History of substance abuse, alcoholism, or psychiatric/neurological disorders (e.g., epilepsy, dementia, hepatic encephalopathy).
- Participation in other clinical trials with investigational drugs within 4 weeks prior to treatment.
- Hypersensitivity to macromolecular protein preparations or any component of the study drugs.
- Live vaccination within 4 weeks prior to treatment.
- Major surgery within 4 weeks prior to treatment or planned during the study.
- Hemoptysis (≥2.5 mL of bright red blood) or clinically significant gastrointestinal bleeding within 2 months prior to treatment.
- Current or history of gastrointestinal obstruction, unless resolved with treatment and deemed eligible by the investigator.
- Hemorrhagic tendency or clinically significant coagulopathy.
- Unhealed wounds, active ulcers, or untreated fractures.
- Recent use of antiplatelet/anticoagulant agents:
- Aspirin (>325 mg/day) or clopidogrel (>75 mg/day) within 10 days prior to treatment;
- Therapeutic anticoagulation (except low-molecular-weight heparin) within 2 weeks prior to treatment.
- Gastrointestinal abnormalities affecting drug absorption (e.g., dysphagia, chronic diarrhea, gastrectomy).
- Any condition that, in the investigator's judgment, increases study risk, confounds results, or renders the patient unsuitable for enrollment.
About this study
Official title: A Phase II Clinical Study of Chidamide in Combination With PD-1 Inhibitor, Bevacizumab, and XELOX as First-Line Treatment for Metastatic Colorectal Cancer
This phase II, open-label, dose-escalation study aims to (1) assess the safety and tolerability of chidamide in combination with PD-1 inhibitor, bevacizumab, and XELOX as first-line therapy for treatment-naïve metastatic colorectal cancer patients, (2) establish the recommended phase II dose (RP2D) of the combination regimen, and (3) obtain preliminary efficacy data including objective response rate (ORR) and progression-free survival (PFS).
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Treatment group, Standard-of-care control group
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment groupDrug
Chidamide+XELOX + Bevacizumab+PD-1
Standard-of-care control groupDrug
XELOX + Bevacizumab+PD-1
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | PD-1 inhibitor: Dose determined per the manufacturer's instructions or investigator's discretion based on patient status.
Bevacizumab: 7.5 mg/kg via intravenous infusion every 3 weeks (Q3W).
XELOX regimen:
Oxaliplatin: 130 mg/m² via intravenous infusion on Day 1;
Capecitabine: 1000 mg/m² orally twice daily on Days 1-14;
Repeated every 3 weeks for 6 cycles.
Maintenance therapy after 6 cycles (experimental group):
Chidamide: Administered at the maximum tolerated dose/recommended phase II dose (MTD/RP2D), orally twice weekly (on Days 1, 4, 8, 11, 15, and 18 of each cycle), 30 minutes after meals.
PD-1 inhibitor, Bevacizumab, and Capecitabine: Continued at the same doses and schedules as during the initial treatment phase. Receives: Drug: Treatment group |
| Standard-of-care control group | Active comparator | XELOX + Bevacizumab: Doses identical to the experimental group (Oxaliplatin 130 mg/m², Capecitabine 1000 mg/m², Bevacizumab 7.5 mg/kg Q3W) for 6 cycles.
Maintenance therapy after 6 cycles: Bevacizumab (7.5 mg/kg Q3W) and Capecitabine (1000 mg/m² orally twice daily on Days 1-14 of each cycle). Receives: Drug: Standard-of-care control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Evaluated using RECIST 1.1 criteria
Measured: 24 months
Secondary outcomes (3)
Objective Response Rate (ORR)
Evaluated using RECIST 1.1 criteria
Measured: 24 months
Overall Survival (OS)
Evaluated using RECIST 1.1 criteria
Measured: 24 months
safety
Based on NCI-CTCAE 5.0 criteria.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start9 Apr 2025 (estimated)
- Primary completion8 Jan 2026 (estimated)
- Study completion8 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AIPING ZHOU, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858969
- Sponsor's protocol ID
- CSIIT-Q100
- Status last verified
- Feb 2025
- First submitted
- 28 Feb 2025
- Last updated
- 5 Mar 2025
- 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 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study of Chidamide in Combination With PD-1 Inhibitor, Bevacizumab, and XELOX as First-Line Treatment for Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06858969
- Acronym / sponsor ID
- CSIIT-Q100
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 9 Apr 2025 (estimated)
- Primary completion
- 8 Jan 2026 (estimated)
- Study completion
- 8 Jan 2028 (estimated)
- First posted
- 5 Mar 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.
This phase II, open-label, dose-escalation study aims to (1) assess the safety and tolerability of chidamide in combination with PD-1 inhibitor, bevacizumab, and XELOX as first-line therapy for treatment-naïve metastatic colorectal cancer patients, (2) establish the recommended phase II dose (RP2D) of the combination regimen, and (3) obtain preliminary efficacy data including objective response rate (ORR) and progression-free survival (PFS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Treatment groupPD-1 inhibitor: Dose determined per the manufacturer's instructions or investigator's discretion based on patient status. Bevacizumab: 7.5 mg/kg via intravenous infusion every 3 weeks (Q3W). XELOX regimen: Oxaliplatin: 130 mg/m² via intravenous infusion on Day 1; Capecitabine: 1000 mg/m² orally twice daily on Days 1-14; Repeated every 3 weeks for 6 cycles. Maintenance therapy after 6 cycles (experimental group): Chidamide: Administered at the maximum tolerated dose/recommended phase II dose (MTD/RP2D), orally twice weekly (on Days 1, 4, 8, 11, 15, and 18 of each cycle), 30 minutes after meals. PD-1 inhibitor, Bevacizumab, and Capecitabine: Continued at the same doses and schedules as during the initial treatment phase. |
| Standard-of-care control group | Active comparator | Drug: Standard-of-care control groupXELOX + Bevacizumab: Doses identical to the experimental group (Oxaliplatin 130 mg/m², Capecitabine 1000 mg/m², Bevacizumab 7.5 mg/kg Q3W) for 6 cycles. Maintenance therapy after 6 cycles: Bevacizumab (7.5 mg/kg Q3W) and Capecitabine (1000 mg/m² orally twice daily on Days 1-14 of each cycle). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years and ≤75 years, regardless of gender; Histologically confirmed unresectable metastatic/recurrent colorectal adenocarcinoma; No prior systemic antitumor therapy received for metastatic/recurrent colorectal adenocarcinoma; For subjects who have received prior neoadjuvant/adjuvant therapy, the interval between the last treatment and recurrence/progression must exceed 12 months; ECOG performance status 0-1; At least one measurable lesion (per RECIST v1.1 criteria); Expected survival ≥3 months;
- Organ function must meet the following requirements prior to the first dose of the investigational drug:
- Hematological function (no blood transfusion or growth factor administration within 14 days before screening):
- Absolute neutrophil count ≥1.5×10^9/L, Platelet count ≥100×10^9/L, Hemoglobin ≥90 g/L;
- Hepatic and renal function (no albumin infusion within 14 days before screening):
Key exclusion criteria (31 listed)
- Subjects with known tumor microsatellite instability-high (MSI-H) status.
- Prior treatment with histone deacetylase (HDAC) inhibitors, including but not limited to chidamide or entinostat.
- Prior postoperative adjuvant therapy targeting EGFR or VEGF/VEGFR, including bevacizumab, cetuximab, panitumumab, aflibercept, regorafenib, or biosimilars of these agents.
- Prior treatment with T-cell co-stimulation or immune checkpoint therapies, including CTLA-4 inhibitors, PD-1/PD-L1/PD-L2 inhibitors, or other T-cell-targeted drugs.
- Active hepatitis B (HBV DNA ≥ 500 IU/mL) or hepatitis C (HCV antibody-positive with HCV-RNA above the lower limit of detection).
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 |
|---|---|---|
| Treatment groupChidamide+XELOX + Bevacizumab+PD-1 | Drug | Treatment group |
| Standard-of-care control groupXELOX + Bevacizumab+PD-1 | Drug | Standard-of-care control group |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 24 months
Evaluated using RECIST 1.1 criteria
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: 24 months
Overall Survival (OS)
Time frame: 24 months
safety
Time frame: 24 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 5 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Treatment group in people with Metastatic Colorectal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
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 31 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 5 Mar 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 24 months). 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 5 Mar 2025.