Colorectal Cancer MetastaticPhase 2NCT06685276
Safety and Efficacy of Fruquintinib Plus Chidamide and Sintilimab in the Third and Later Line Treatment of MSS/pMMR Metastatic Colorectal Cancer
A Phase 2 study testing Fruquintinib, Sintilimab and Chidamide in people with Colorectal Cancer Metastatic, run by Dai, Guanghai at 1 site in China.
Trial summary
The prognosis of most patients with unresectable locally advanced or metastatic colorectal cancer (CRC) remains poor despite the advancements in chemotherapy and target therapy. CAPability-01 trial investigated the potential efficacy of combining the programmed cell death protein-1 (PD-1) monoclonal antibody… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- Fruquintinib, Sintilimab and Chidamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 16 Aug 2024to Dec 2026
- 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
- Fully understand this study and voluntarily sign the informed consent form;
- Age between 18-75 years inclusive;
- Patients with histologically confirmed unresectable locally advanced, recurrent, or metastatic colorectal adenocarcinoma;
- Failure of standard second-line systemic treatment with measurable lesions;
- Tumor tissue tested for microsatellite stability (MSS) or low microsatellite instability (MSI-L) by PCR, or confirmed pMMR by immunohistochemistry for DNA mismatch repair (MMR) protein (including MLH1, MSH2, MSH6, and PMS2 protein expression);
- ECOG performance status of 0-2, with no deterioration within 7 days;
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- BMI≥18;
- Expected survival ≥3 months;
- Major organ functions meet the following requirements (no use of any blood components and growth factors within 14 days before enrollment):
- Absolute neutrophil count ≥1.5×109/L, white blood cells ≥4.0×109/L;
- Platelets ≥100×109/L;
- Hemoglobin ≥90g/L;
- Total bilirubin TBIL ≤1.5 times ULN;
- ALT and AST ≤5 times ULN;
- Urea/BUN and creatinine (Cr) ≤1.5×ULN (and creatinine clearance (CCr) ≥ 50mL/min);
- Left ventricular ejection fraction (LVEF) ≥50%;
- Corrected QT interval by Fridericia's formula (QTcF) <470 milliseconds.
- INR ≤1.5×ULN, APTT ≤1.5×ULN.
- Women of childbearing age must use effective contraception;
- Good compliance and cooperation with follow-up.
Who cannot join
- Unable to comply with the study protocol or procedures;
- Pregnant or breastfeeding women;
- Concurrent with any of the following conditions: uncontrolled hypertension, coronary artery disease, arrhythmias, and heart failure;
- Previous treatment with small molecule tyrosine kinase inhibitors for metastatic disease;
- Previous treatment with romidepsin;
- Previous treatment with immune checkpoint inhibitors for metastatic disease;
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- Uncontrollable severe concurrent infections;
- Acute myocardial infarction, acute coronary syndrome, or CABG within 3 months before the first treatment;
- Subjects allergic to the study medication or any of its excipients;
- Known human immunodeficiency virus (HIV) infection. Known clinically significant liver disease history, including viral hepatitis [known carriers of hepatitis B virus (HBV) must exclude active HBV infection, i.e., HBV DNA positive (>1×10^4 copies/mL or >2000 IU/mL); known hepatitis C virus (HCV) infection and HCV RNA positive (>1×10^3 copies/mL)];
- 12. Patients whom the investigator deems inappropriate 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
China PLAGH
Beijing
Guanghai Dai, M.D., 13801232381, daigh301@vip.sina.com
About this study
Official title: A Prospective Single-arm Phase Ib/II Study on the Safety and Efficacy of Fruquintinib Plus Chidamide and Sintilimab in the Third and Later Line Treatment of MSS/pMMR Metastatic Colorectal Cancer
The prognosis of most patients with unresectable locally advanced or metastatic colorectal cancer (CRC) remains poor despite the advancements in chemotherapy and target therapy.
CAPability-01 trial investigated the potential efficacy of combining the programmed cell death protein-1 (PD-1) monoclonal antibody sintilimab with the histone deacetylase inhibitor (HDACi) chidamide with or without the anti-vascular endothelial growth factor (VEGF) monoclonal antibody bevacizumab in patients with unresectable chemotherapy-refractory locally advanced or metastatic microsatellite stable/proficient mismatch repair (MSS/pMMR) colorectal cancer.
Based on the previous findings of CAPability-01, we will further evaluate the efficacy and safety of sintilimab and chidamide in combination with fruquintinib in the same setting.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- Fruquintinib, Sintilimab, Chidamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FruquintinibDrug
Also called hmpl-013
Fruquintinib: 5mg qd, po, 2 weeks on/1 week off, q3w, or 3mg qd, po, q3w.
SintilimabDrug
Sintilimab: 200mg, iv, d1, q3w.
ChidamideDrug
Chidamide: 30mg/m2, po, biw.
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Fruquintinib Sintilimab Chidamide
Treatments are administered until disease progression or toxicity intolerable. Receives: Drug: Fruquintinib; Drug: Sintilimab; Drug: Chidamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress-free Survival(PFS)
The time from enrollment until tumor progression or death from any cause, whichever occurred first
Measured: 24 months
Secondary outcomes (4)
Objective response rate (ORR)
The proportion of patients with a PR or CR
Measured: 24 months
Overall Survival (OS)
The time calculated from enrollment until death from any cause, with living patients censored at the last known survival date
Measured: 24 months
Disease control rate (DCR)
The proportion of patients with a PR, CR, or SD
Measured: 24 months
Duration of response (DoR)
For patients who achieved a complete response (CR) or partial response (PR), the time from the first tumor assessment demonstrating response until disease progression or death, whichever occurred first
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 posted12 Nov 2024
- Study start16 Aug 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (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
- 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
- Dai, Guanghai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dai, Guanghai, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685276
- Sponsor's protocol ID
- 2024-415
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-arm Phase Ib/II Study on the Safety and Efficacy of Fruquintinib Plus Chidamide and Sintilimab in the Third and Later Line Treatment of MSS/pMMR Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06685276
- Acronym / sponsor ID
- 2024-415
- Conditions
- Colorectal Cancer Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Dai, GuanghaiUniversity, hospital or other
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (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.
The prognosis of most patients with unresectable locally advanced or metastatic colorectal cancer (CRC) remains poor despite the advancements in chemotherapy and target therapy.
CAPability-01 trial investigated the potential efficacy of combining the programmed cell death protein-1 (PD-1) monoclonal antibody sintilimab with the histone deacetylase inhibitor (HDACi) chidamide with or without the anti-vascular endothelial growth factor (VEGF) monoclonal antibody bevacizumab in patients with unresectable chemotherapy-refractory locally advanced or metastatic microsatellite stable/proficient mismatch repair (MSS/pMMR) colorectal cancer.
Based on the previous findings of CAPability-01, we will further evaluate the efficacy and safety of sintilimab and chidamide in combination with fruquintinib in the same setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Drug: Fruquintinib, Drug: Sintilimab, Drug: ChidamideFruquintinib Sintilimab Chidamide Treatments are administered until disease progression or toxicity intolerable. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Fully understand this study and voluntarily sign the informed consent form;
- Age between 18-75 years inclusive;
- Patients with histologically confirmed unresectable locally advanced, recurrent, or metastatic colorectal adenocarcinoma;
- Failure of standard second-line systemic treatment with measurable lesions;
- Tumor tissue tested for microsatellite stability (MSS) or low microsatellite instability (MSI-L) by PCR, or confirmed pMMR by immunohistochemistry for DNA mismatch repair (MMR) protein (including MLH1, MSH2, MSH6, and PMS2 protein expression);
Key exclusion criteria (11 listed)
- Unable to comply with the study protocol or procedures;
- Pregnant or breastfeeding women;
- Concurrent with any of the following conditions: uncontrolled hypertension, coronary artery disease, arrhythmias, and heart failure;
- Previous treatment with small molecule tyrosine kinase inhibitors for metastatic disease;
- Previous treatment with romidepsin;
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 |
|---|---|---|
| FruquintinibAlso: hmpl-013Fruquintinib: 5mg qd, po, 2 weeks on/1 week off, q3w, or 3mg qd, po, q3w. | Drug | Study arm |
| SintilimabSintilimab: 200mg, iv, d1, q3w. | Drug | Study arm |
| ChidamideChidamide: 30mg/m2, po, biw. | Drug | Study arm |
Primary outcome
Progress-free Survival(PFS)
Time frame: 24 months
The time from enrollment until tumor progression or death from any cause, whichever occurred first
4 secondary outcomes
Objective response rate (ORR)
Time frame: 24 months
Overall Survival (OS)
Time frame: 24 months
Disease control rate (DCR)
Time frame: 24 months
Duration of response (DoR)
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 20 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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 and Chidamide in people with Colorectal Cancer Metastatic, run by Dai, Guanghai 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 20 inclusion and 11 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 Nov 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress-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 20 Nov 2024.