Refractory Metastatic Colorectal CancerPhase 2NCT07896096
Ivarmacitinib Combined With Camrelizumab and Fruquintinib for Patients With Metastatic Colorectal Cancer After Failure of Second-line or Later Treatment
A Phase 2 study testing Ivarmacitinib Sulfate Tablets, Camrelizumab and Fruquintinib in people with Refractory Metastatic Colorectal Cancer, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
For patients with metastatic colorectal cancer (mCRC) who have failed two or more lines of standard therapy, treatment options are extremely limited, and the prognosis remains poor, with objective response rates (ORRs) generally below 5%. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Refractory Metastatic Colorectal Cancer
- What is being tested?
- Ivarmacitinib Sulfate Tablets, Camrelizumab and Fruquintinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 14 Apr 2026to 30 Jun 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
- Histologically or cytologically confirmed advanced, metastatic, or recurrent colorectal cancer, supported by radiological findings.
- Age 18-75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Disease progression or failure of at least second-line standard therapy.
- Voluntary provision of written informed consent.
Who cannot join
- Prior treatment with a JAK1 inhibitor.
- Active autoimmune disease or primary immunodeficiency within the previous 2 years.
- Known allergy to monoclonal antibodies, sodium carboxymethylcellulose, or any of their components.
- Major cardiovascular or cerebrovascular diseases, including stroke or myocardial infarction within 6 months before enrollment, uncontrolled hypertension, unstable angina, heart failure (New York Heart Association [NYHA] class II-IV), or severe arrhythmias requiring pharmacological treatment.
- History of other malignancies within 5 years before enrollment, except for excised basal cell carcinoma of the skin or cervical carcinoma in situ.
- Membership in vulnerable populations, including individuals with mental or cognitive impairment, critically ill patients, minors, pregnant or breastfeeding women.
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- Severe chronic obstructive pulmonary disease (COPD), interstitial lung disease, or other conditions that severely impair pulmonary function.
- Severe hepatic impairment, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 × the upper limit of normal (ULN) in patients without liver metastases, or ≥ 5 × ULN in patients with liver metastases.
- Severe renal impairment, defined as creatinine clearance (CrCl) < 30 mL/min.
- Toxicities from previous anticancer treatment that have not recovered to Grade 1 or lower, except for alopecia.
- History of venous thrombosis.
- Active tuberculosis or active bacterial, fungal, or viral infection.
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
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430000
Dr. Chai, +86 136 8725 4115, 874793147@qq.com
About this study
Official title: A Phase II Study of Ivarmacitinib Combined With Camrelizumab and Fruquintinib for Patients With Metastatic Colorectal Cancer After Failure of Second-line or Later Treatment
For patients with metastatic colorectal cancer (mCRC) who have failed two or more lines of standard therapy, treatment options are extremely limited, and the prognosis remains poor, with objective response rates (ORRs) generally below 5%. This is particularly challenging for patients with microsatellite-stable (MSS)/proficient mismatch repair (pMMR) tumors, who constitute the vast majority of patients with mCRC. The immunologically "cold" tumor microenvironment (TME) in these patients contributes to widespread primary resistance to PD-1 inhibitor monotherapy. A key mechanism underlying this resistance is the sustained activation of JAK/STAT signaling, which promotes immunosuppression mediated by myeloid-derived suppressor cells (MDSCs) and other immunosuppressive components, thereby limiting T-cell activity and the efficacy of strategies that solely reinvigorate T cells.
To address this challenge, the investigators propose an innovative combination strategy aimed at remodeling the TME and alleviating immunosuppression. The investigators hypothesize that ivarmacitinib, a highly selective JAK1 inhibitor, may attenuate the immunosuppressive TME through modulation of JAK/STAT signaling, potentially converting "cold" tumors into "hot" tumors and enhancing the antitumor activity of camrelizumab, a PD-1 inhibitor, in combination with fruquintinib, a tyrosine kinase inhibitor (TKI). Accordingly, a single-arm, single-center, exploratory phase II clinical study was designed to enroll 33 patients with mCRC who have failed multiple lines of prior therapy. The study aims to evaluate the ORR, survival outcomes, and safety of this combination regimen. The findings are expected to provide preliminary evidence for a potential new therapeutic approach for this heavily pretreated patient population and establish a foundation for subsequent larger confirmatory studies.
- Conditions
- Refractory Metastatic Colorectal Cancer
- Being tested
- Ivarmacitinib Sulfate Tablets, Camrelizumab, Fruquintinib
- Keywords
- Metastatic colorectal cancer, Immunotherapy, Tumor microenvironment
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivarmacitinib Sulfate TabletsDrug
Ivarmacitinib will be administered orally at a dose of 4 mg once daily for 2 weeks during the lead-in phase. During the combination induction phase, treatment will continue at 4 mg orally once daily. Ivarmacitinib will be discontinued after completion of the combination induction phase, unless earlier discontinuation is required.
CamrelizumabDrug
Camrelizumab will be administered intravenously at a dose of 200 mg once every 3 weeks during the combination induction phase and the maintenance phase. During the maintenance phase, camrelizumab will be administered for 15 cycles. Treatment will be discontinued upon completion of the planned treatment period, disease progression, unacceptable toxicity, or fulfillment of another protocol-defined discontinuation criterion.
FruquintinibDrug
Fruquintinib will be administered orally at a dose of 5 mg once daily for 14 consecutive days, followed by 7 days off treatment, constituting a 21-day cycle. This regimen will be administered during the combination induction phase and the maintenance phase. Treatment will be discontinued upon completion of the planned treatment period, disease progression, unacceptable toxicity, or fulfillment of another protocol-defined discontinuation criterion.
| Study group | Role | What they receive |
|---|---|---|
| Ivarmacitinib + Camrelizumab + Fruquintinib | Experimental | Not described Receives: Drug: Ivarmacitinib Sulfate Tablets; Drug: Camrelizumab; Drug: Fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-free survival (PFS) is defined as the time from the first dose of study treatment to the first documented disease progression, as assessed according to RECIST version 1.1, or death from any cause, whichever occurs first. PFS will be estimated using the Kaplan-Meier method.
Measured: From the first dose of study treatment through study completion, an average of 1 year
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the proportion of participants achieving a complete response (CR) or partial response (PR), as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: Baseline through study completion, an average of 1 year
Disease Control Rate (DCR)
Disease control rate (DCR) is defined as the proportion of participants achieving a complete response (CR), partial response (PR), or stable disease (SD), as assessed according to RECIST version 1.1.
Measured: Baseline through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start14 Apr 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Metastatic Colorectal CancerStudies 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
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896096
- Sponsor's protocol ID
- WDRY2026-K014
- Other IDs
- 288353
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 28 Oct 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Ivarmacitinib Combined With Camrelizumab and Fruquintinib for Patients With Metastatic Colorectal Cancer After Failure of Second-line or Later Treatment
- ClinicalTrials.gov ID
- NCT07896096
- Acronym / sponsor ID
- WDRY2026-K014
- Conditions
- Refractory Metastatic Colorectal Cancer
- Keywords
- Metastatic colorectal cancer, Immunotherapy, Tumor microenvironment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 26 Oct 2026 (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.
For patients with metastatic colorectal cancer (mCRC) who have failed two or more lines of standard therapy, treatment options are extremely limited, and the prognosis remains poor, with objective response rates (ORRs) generally below 5%. This is particularly challenging for patients with microsatellite-stable (MSS)/proficient mismatch repair (pMMR) tumors, who constitute the vast majority of patients with mCRC. The immunologically "cold" tumor microenvironment (TME) in these patients contributes to widespread primary resistance to PD-1 inhibitor monotherapy. A key mechanism underlying this resistance is the sustained activation of JAK/STAT signaling, which promotes immunosuppression mediated by myeloid-derived suppressor cells (MDSCs) and other immunosuppressive components, thereby limiting T-cell activity and the efficacy of strategies that solely reinvigorate T cells.
To address this challenge, the investigators propose an innovative combination strategy aimed at remodeling the TME and alleviating immunosuppression. The investigators hypothesize that ivarmacitinib, a highly selective JAK1 inhibitor, may attenuate the immunosuppressive TME through modulation of JAK/STAT signaling, potentially converting "cold" tumors into "hot" tumors and enhancing the antitumor activity of camrelizumab, a PD-1 inhibitor, in combination with fruquintinib, a tyrosine kinase inhibitor (TKI). Accordingly, a single-arm, single-center, exploratory phase II clinical study was designed to enroll 33 patients with mCRC who have failed multiple lines of prior therapy. The study aims to evaluate the ORR, survival outcomes, and safety of this combination regimen. The findings are expected to provide preliminary evidence for a potential new therapeutic approach for this heavily pretreated patient population and establish a foundation for subsequent larger confirmatory studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ivarmacitinib + Camrelizumab + Fruquintinib | Experimental | Drug: Ivarmacitinib Sulfate Tablets, Drug: Camrelizumab, Drug: Fruquintinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed advanced, metastatic, or recurrent colorectal cancer, supported by radiological findings.
- Age 18-75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Disease progression or failure of at least second-line standard therapy.
Key exclusion criteria (12 listed)
- Prior treatment with a JAK1 inhibitor.
- Active autoimmune disease or primary immunodeficiency within the previous 2 years.
- Known allergy to monoclonal antibodies, sodium carboxymethylcellulose, or any of their components.
- Major cardiovascular or cerebrovascular diseases, including stroke or myocardial infarction within 6 months before enrollment, uncontrolled hypertension, unstable angina, heart failure (New York Heart Association [NYHA] class II-IV), or severe arrhythmias requiring pharmacological treatment.
- History of other malignancies within 5 years before enrollment, except for excised basal cell carcinoma of the skin or cervical carcinoma in situ.
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 |
|---|---|---|
| Ivarmacitinib Sulfate TabletsIvarmacitinib will be administered orally at a dose of 4 mg once daily for 2 weeks during the lead-in phase. During the combination induction phase, treatment will continue at 4 mg orally once daily. Ivarmacitinib will be discontinued after completion of the combination induction phase, unless earlier discontinuation is required. | Drug | Ivarmacitinib + Camrelizumab + Fruquintinib |
| CamrelizumabCamrelizumab will be administered intravenously at a dose of 200 mg once every 3 weeks during the combination induction phase and the maintenance phase. During the maintenance phase, camrelizumab will be administered for 15 cycles. Treatment will be discontinued upon completion of the planned treatment period, disease progression, unacceptable toxicity, or fulfillment of another protocol-defined discontinuation criterion. | Drug | Ivarmacitinib + Camrelizumab + Fruquintinib |
| FruquintinibFruquintinib will be administered orally at a dose of 5 mg once daily for 14 consecutive days, followed by 7 days off treatment, constituting a 21-day cycle. This regimen will be administered during the combination induction phase and the maintenance phase. Treatment will be discontinued upon completion of the planned treatment period, disease progression, unacceptable toxicity, or fulfillment of another protocol-defined discontinuation criterion. | Drug | Ivarmacitinib + Camrelizumab + Fruquintinib |
Primary outcome
PFS
Time frame: From the first dose of study treatment through study completion, an average of 1 year
Progression-free survival (PFS) is defined as the time from the first dose of study treatment to the first documented disease progression, as assessed according to RECIST version 1.1, or death from any cause, whichever occurs first. PFS will be estimated using the Kaplan-Meier method.
Objective Response Rate (ORR)
Time frame: Baseline through study completion, an average of 1 year
Objective response rate (ORR) is defined as the proportion of participants achieving a complete response (CR) or partial response (PR), as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Disease Control Rate (DCR)
Time frame: Baseline through study completion, an average of 1 year
Disease control rate (DCR) is defined as the proportion of participants achieving a complete response (CR), partial response (PR), or stable disease (SD), as assessed according to RECIST version 1.1.
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 28 Oct 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.
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 Ivarmacitinib Sulfate Tablets, Camrelizumab and Fruquintinib in people with Refractory Metastatic Colorectal Cancer, run by Renmin Hospital of Wuhan 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 6 inclusion and 12 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 28 Oct 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 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 Dr. Lin (+86 177 6257 5104, 236772452@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: From the first dose of study treatment through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 28 Oct 2026.