Metastatic Colorectal CancerPhase 2NCT06979908
A Clinical Study on the Efficacy and Safety of Fruquintinib in Combination With PD-1 Monoclonal Antibody and Chidamide in Refractory MSS Metastatic Colorectal Cancer
A Phase 2 study testing Fruquintinib+Sintilimab+Chidamide in people with Metastatic Colorectal Cancer, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
This study is a single-arm, open-label, single-center clinical trial designed to evaluate the efficacy and safety of fruquintinib in combination with a PD-1 inhibitor and chidamide in patients with refractory MSS-type metastatic colorectal cancer (mCRC). 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?
- Fruquintinib+Sintilimab+Chidamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2025to 22 Jan 2027
- 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
- Signed informed consent and ability to comply with the study protocol.
- Age ≥18 years and ≤75 years.
- Histologically confirmed colorectal adenocarcinoma.
- Unresectable locally advanced, unresectable recurrent, and/or metastatic disease (i.e., advanced disease not amenable to curative treatments such as radical radiotherapy, chemoradiotherapy, and/or surgery) after failure of ≥2 prior lines of standard therapy.
- At least one measurable lesion as per RECIST v1.1.
- ECOG performance status of 0 or 1.
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- Life expectancy ≥3 months.
- Adequate bone marrow, liver, and renal function:
- ANC ≥1.5 × 10⁹/L (1500/µL) Platelet count ≥100 × 10⁹/L (100,000/μL) Hemoglobin ≥90 g/L (9 g/dL) For patients without liver metastases: AST/ALT ≤2.5 × ULN For patients with liver metastases: AST/ALT ≤5 × ULN Total bilirubin ≤1.5 × ULN Serum creatinine ≤1.5 × ULN and creatinine clearance ≥60 mL/min
- For women of childbearing potential (WOCBP): Negative urine or serum pregnancy test within 3 days prior to the first dose of study treatment.
- Contraception requirement: All subjects (male or female) at risk of conception must use highly effective contraception (failure rate <1% per year) throughout the treatment period and for 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy, if applicable).
Who cannot join
- Palliative radiotherapy for colorectal cancer within 4 weeks prior to initiation of study treatment.
- Use of traditional Chinese medicine (TCM) or Chinese herbal preparations for cancer control within 7 days before starting study treatment.
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
- Other severe uncontrolled comorbidities (e.g., interstitial lung disease, epilepsy, hepatic failure, etc.).
- Current or history of autoimmune diseases or immunodeficiency disorders.
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonia on screening chest CT.
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- Severe chronic or active infection requiring treatment within 4 weeks prior to study treatment initiation.
- Major surgery (excluding diagnostic procedures) within 4 weeks before study treatment or anticipated need for major surgery during the study period.
- Clinically significant cardiovascular disease, including:Symptomatic congestive heart failure (CHF),Poorly controlled hypertension,Unstable angina,Arrhythmias,Myocardial infarction within 6 months,Arterial thromboembolism or pulmonary embolism within 3 months before the first dose.
- History of other malignancies (except the cancer under investigation) within 2 years prior to screening.
- Prior immune checkpoint inhibitor therapy (e.g., anti-CTLA-4, anti-PD-1, anti-PD-L1).mmunostimulatory agents (e.g., IFN, IL-2) within 4 weeks before study treatment, or 5 drug elimination half-lives (whichever is longer).
- Chemotherapy, immunotherapy (e.g., IL, IFN, thymosin), or any investigational therapy within 14 days before study treatment, or5 drug elimination half-lives (whichever is longer).
- Active or chronic infections, including:HIV-positive,Active hepatitis B (HBV) or hepatitis C (HCV), or related medical history.
- For HBV carriers (HBsAg+ or HBcAb+):HBV DNA must be ≤2.5×10³ copies/mL (or ≤500 IU/mL) or below detection limit to enroll.Antiviral therapy for HBV is mandatory throughout the study.For HCV-seropositive patients:HCV RNA must be negative or below detection limit for enrollment.
- Any other condition deemed by the investigator to increase the risk of premature study termination.
- Patients who required systemic corticosteroid therapy (>10 mg/day prednisone or equivalent) or other immunosuppressants within 14 days prior to the first dose. In the absence of active autoimmune disease, inhaled or topical corticosteroids are permitted, as well as adrenal replacement therapy at doses ≤10 mg/day prednisone equivalent.
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
The First Hospital of Jilin University
Changchun, Jilin
About this study
This study is a single-arm, open-label, single-center clinical trial designed to evaluate the efficacy and safety of fruquintinib in combination with a PD-1 inhibitor and chidamide in patients with refractory MSS-type metastatic colorectal cancer (mCRC). A total of 46 patients are planned to be enrolled, with the primary endpoint being median progression-free survival (mPFS). Secondary endpoints include median overall survival (mOS), objective response rate (ORR), and safety.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Fruquintinib+Sintilimab+Chidamide
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruquintinib+Sintilimab+ChidamideDrug
Fruquintinib: 5 mg orally once daily on days 1-14 of each 21-day cycle (Q3W).
Sintilimab (anti-PD-1): 200 mg intravenously on day 1 of each cycle (first infusion over 60 minutes, subsequent infusions over 30-60 minutes, Q3W).
Chidamide: 30 mg orally twice weekly (BIW; e.g., Monday \& Thursday or Tuesday \& Friday, with ≥3 days between doses), taken 30 minutes after meals.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Fruquintinib: 5 mg, once daily, orally, on days 1-14, every 3 weeks (Q3W); Sintilimab (PD-1 inhibitor): 200 mg, once per cycle, intravenous infusion (first infusion over 60 minutes, subsequent infusions over 30-60 minutes), on day 1, Q3W; Chidamide: 30 mg, twice weekly (BIW), orally (with at least 3 days between doses, taken 30 minutes after meals). Receives: Drug: Fruquintinib+Sintilimab+Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-Free Survival
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 posted20 May 2025
- Study start22 Jan 2025
- Primary completion22 Jul 2026 (estimated)
- Study completion22 Jan 2027 (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 The First Hospital of Jilin UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Chang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979908
- Sponsor's protocol ID
- CSIIT-Q103
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 20 May 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 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Efficacy and Safety of Fruquintinib in Combination With PD-1 Monoclonal Antibody and Chidamide in Refractory MSS Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06979908
- Acronym / sponsor ID
- CSIIT-Q103
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 22 Jul 2026 (estimated)
- Study completion
- 22 Jan 2027 (estimated)
- First posted
- 20 May 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 study is a single-arm, open-label, single-center clinical trial designed to evaluate the efficacy and safety of fruquintinib in combination with a PD-1 inhibitor and chidamide in patients with refractory MSS-type metastatic colorectal cancer (mCRC). A total of 46 patients are planned to be enrolled, with the primary endpoint being median progression-free survival (mPFS). Secondary endpoints include median overall survival (mOS), objective response rate (ORR), and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Fruquintinib+Sintilimab+ChidamideFruquintinib: 5 mg, once daily, orally, on days 1-14, every 3 weeks (Q3W); Sintilimab (PD-1 inhibitor): 200 mg, once per cycle, intravenous infusion (first infusion over 60 minutes, subsequent infusions over 30-60 minutes), on day 1, Q3W; Chidamide: 30 mg, twice weekly (BIW), orally (with at least 3 days between doses, taken 30 minutes after meals). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed informed consent and ability to comply with the study protocol.
- Age ≥18 years and ≤75 years.
- Histologically confirmed colorectal adenocarcinoma.
- Unresectable locally advanced, unresectable recurrent, and/or metastatic disease (i.e., advanced disease not amenable to curative treatments such as radical radiotherapy, chemoradiotherapy, and/or surgery) after failure of ≥2 prior lines of standard therapy.
- At least one measurable lesion as per RECIST v1.1.
Key exclusion criteria (16 listed)
- Palliative radiotherapy for colorectal cancer within 4 weeks prior to initiation of study treatment.
- Use of traditional Chinese medicine (TCM) or Chinese herbal preparations for cancer control within 7 days before starting study treatment.
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
- Other severe uncontrolled comorbidities (e.g., interstitial lung disease, epilepsy, hepatic failure, etc.).
- Current or history of autoimmune diseases or immunodeficiency disorders.
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 |
|---|---|---|
| Fruquintinib+Sintilimab+ChidamideFruquintinib: 5 mg orally once daily on days 1-14 of each 21-day cycle (Q3W). Sintilimab (anti-PD-1): 200 mg intravenously on day 1 of each cycle (first infusion over 60 minutes, subsequent infusions over 30-60 minutes, Q3W). Chidamide: 30 mg orally twice weekly (BIW; e.g., Monday \& Thursday or Tuesday \& Friday, with ≥3 days between doses), taken 30 minutes after meals. | Drug | Experimental Arm |
Primary outcome
PFS
Time frame: 24 months
Progression-Free Survival
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 20 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fruquintinib+Sintilimab+Chidamide in people with Metastatic Colorectal Cancer, run by The First Hospital of Jilin University 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 11 inclusion and 16 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 20 May 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.
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?
Contact Chang Wang (15804302610, wangchang@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 20 May 2025.