Colorectal CancerPhase 2NCT06558773
GSL Synthetase Inhibitor Plus Immune Checkpoint Inhibitor and/or Regorafenib in Previously Treated pMMR/MSS CRC.
A Phase 2 study testing Regorafenib+Immune checkpoint inhibitor, Eliglustat+Immune checkpoint inhibitor and Eliglustat+Immune checkpoint inhibitor +Regorafenib in people with Colorectal Cancer, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
In this single-center,open-label, randomized, phase II study, the efficacy and feasibility of GSL synthetase inhibitor in combination with immune checkpoint inhibitor and/or regorafenib therapeutic regimen will be evaluated in patients with advanced/metastatic proficient mismatch repair/microsatellite stable… 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?
- Regorafenib+Immune checkpoint inhibitor, Eliglustat+Immune checkpoint inhibitor and Eliglustat+Immune checkpoint inhibitor +Regorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 31 Mar 2029
- 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 old and ≤75 years old.
- Histologically confirmed diagnosis of unresectable locally advanced, recurrent or metastatic colorectal cance have failed at least two lines of prior treatment.
- Tumor tissues were identified as pMMR by immunohistochemistry (IHC) method or MSS by polymerase chain reaction (PCR).
- CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs).
- Eastern Cooperative Oncology Group (ECOG) performance status score≤2 and Estimated life expectancy of more than 3 months.
- At least one measurable lesion at baseline according to RECIST version 1.1.
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- Fresh solid tumor samples or formalin-fixed paraffin embedded tumor archival samples within 6 months are necessary; Fresh tumor samples are preferred. Subjects are willing to accept tumor rebiopsy in the process of this study.
- Have adequate organ function as assessed by the laboratory required by protocol, which should be confirmed within 2 weeks prior to the first dose of study drugs.
- Previous treatment must be completed for more than 4 weeks prior to the enrollment of this study, and subjects have recovered to <= grade 1 toxicity.
- Previous treatment with anti-PD-1/PD-L1 antibodies or cytotoxic T lymphocyte associated antigen 4 (CTLA-4) inhibitors are allowed.
- Pregnancy tests for women of childbearing age shall be negative; Both men and women agreed to use effective contraception during treatment and during the subsequent 1 year.
- Ability to understand and sign a written informed consent document.
Who cannot join
- Participants with dMMR /MSI-H colorectal cancer.
- CYP2D6 ultra-rapid metabolizers (URMs).
- Active, known or suspected autoimmune diseases.
- The patients is taking a CYP2D6 inhibitor and/or concomitantly with a strong or moderate CYP3A inhibitor.
- Subjects are being treated with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment.
- History of severe hypersensitive reactions to other monoclonal antibodies.
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- History of allergy or intolerance to study drug components.
- Known brain metastases or active central nervous system (CNS). Subjects with CNS metastases who were treated with radiotherapy for at least 3 months prior to enrollment, have no central nervous symptoms and are off corticosteroids, are eligible for enrollment, but require a brain MRI screening.
- Uncontrolled intercurrent illness, including ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (excluding insignificant sinus bradycardia and sinus tachycardia) or psychiatric illness/social situations and any other illness that would limit compliance with study requirements and jeopardize the safety of the patient.
- Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS).
- Previous or concurrent cancer within 3 years prior to treatment start EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].
- Major surgery or trauma occurred within 28 days prior to enrollment, or major side effects have not been recovered.
- Vaccination within 30 days of study enrollment.
- Active bleeding or known hemorrhagic tendency.Any life Threatening bleeding within 3 months prior to the enrollment.
- Uncontrolled hypertension (systolic pressure >150 mm Hg or diastolic pressure > 100 mm Hg on repeated measurement) despite optimal medical management.
- Pregnant or breast-feeding. Women of childbearing potential must have a pregnancy test performed within 7 days before the enrollment, and a negative result must be documented
- Being participating any other trials or withdraw within 4 weeks.
- Researchers believe that other reasons are not suitable for clinical trials.
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
Beijing, Biotherapeutic Department of Chinsese PLA Gereral Hospital
Weidong Han, Ph.D, 010-66937231, hanwdrsw@sina.com
Yang Liu, M.D, 010-66939460, liuyang301blood@163.com
About this study
Official title: GSL Synthetase Inhibitor in Combination With Immune Checkpoint Inhibitor and/or Regorafenib for Patients With Advanced/Metastatic pMMR/MSS Colorectal Cancer:an Open-Label, Randomized,Phase II Study
In this single-center,open-label, randomized, phase II study, the efficacy and feasibility of GSL synthetase inhibitor in combination with immune checkpoint inhibitor and/or regorafenib therapeutic regimen will be evaluated in patients with advanced/metastatic proficient mismatch repair/microsatellite stable (pMMR/MSS) colorectal cancer (CRC).In this clinical trial, a total of 120 eligible patients were stratified randomly (with/without liver metastases) assigned to the 3 arms in a 1:1:1 ratio: comparator group-arm A (Regorafenib+Immune checkpoint inhibitor) ,experimental group-arm B (Eliglustat+Immune checkpoint inhibitor) and experimental group-arm C (Eliglustat+Immune checkpoint inhibitor+Regorafenib).It aims to: 1).assess the antitumor effects of GSL synthetase inhibitor in combination with immune checkpoint inhibitor and/or regorafenib;2).evaluate the immunological or clinical predictive biomarkers for efficacy and toxicity; 3).detect the transformation of tumor microenvironment (TME) and dynamic changes of immune cells in peripheral blood after the treatment with GSL synthetase inhibitor in combination with immune checkpoint inhibitor and/or regorafenib.
Read the detailed description
Immunotherapy has achieved significant therapeutic effect in DNA mismatch repair-deficient or microsatellite instability-high (dMMR/MSI-H) metastatic colorectal cancer(mCRC). Distinct from those with dMMR/MSI-H mCRC, isolated immunotherapy has proven to be almost ineffective for patients with pMMR/MSS type mCRC,which indicating a worse prognosis.
Previous work has established that the TME is distinct between MSI-H and MSS CRC. Therapeutic combinations of targeted therapy and immunotherapy,such as regorafenib combined with programmed death 1(PD-1) monoclonal antibody ,which can alter the TME and successfully promote favorable immune modulation has attracted extensive attention.Based on the small sample clinical trial results of other regorafenib combined with anti-PD-1 monoclonal antibody , the overall ORR is between 0% and 33.3%, the ORR for non-liver metastases is between 20% and 50%, and the ORR for liver metastases is between 0% and 15%,demonstrating limited clinical benefit.
Besides TME,another important reason is that tumor cells often escape from immune surveillance by downregulating one or multiple molecules critical in human leukocyte antigen (HLA ) antigen presentation. As a consequence, options that could restore HLA antigen presentation may augment immune checkpoint inhibitor-mediated immune responses.
Abnormal expression of glycosphingolipid (GSL) synthetase is a basic and specific characteristic of most tumors and tumor microenvironment, such as Globo H Ceramide, which is overexpressed in multiple epithelial-derived tumors. Several studies also reported that GSL synthetase was overexpressed in chemotherapy-resistant tumors. Eliglustat is an orally GlcCer synthase inhibitor, which is approved for treating Type-1 Gaucher disease. However, one most recent study reveals that it could inhibit glycosphingolipids synthesis and restore HLA antigen presentation, and transforming the immunogenicity of tumor cells.The investigators has demonstrated the excellent safety and efficacy of the combination of Eliglustat and immune checkpoint inhibitor in advanced/ metastatic solid tumors and r/r hematological malignancies,especially in pMMR/MSS mCRC (even with liver metastases).
Based on the above reasons, we designed this open-label, randomized,phase II study to observe the efficacy and feasibility of the GSL synthetase inhibitor in combination with immune checkpoint Inhibitor and/or regorafenib for patients with advanced/metastatic pMMR/MSS CRC and strive to provide a high-level evidence-based basis for combination therapy regimen for these patients. A total of 120 advanced/metastatic pMMR/MSS CRC patients were stratified randomly (with/without liver metastases) assigned to the 3 arms in a 1:1:1 ratio: comparator group-Arm A (Regorafenib+Immune checkpoint inhibitor),experimental group-Arm B(Eliglustat+Immune checkpoint inhibitor) and experimental group-Arm C (Eliglustat+Immune checkpoint inhibitor+Regorafenib).The primary objective of this study is to assess the efficacy and feasibility of the above two experimental groups.The exploratory objectives are to evaluate the immunological or clinical predictive biomarkers for efficacy and toxicity, transformation of tumor microenvironment and dynamic changes of immune cells in peripheral blood.
- Conditions
- Colorectal Cancer
- Being tested
- Regorafenib+Immune checkpoint inhibitor, Eliglustat+Immune checkpoint inhibitor, Eliglustat+Immune checkpoint inhibitor +Regorafenib
- Keywords
- GSL synthetase inhibitor, Immune checkpoint inhibitor, regorafenib
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regorafenib+Immune checkpoint inhibitorDrug
Also called Regorafenib(Stivarga)
Regorafenib orally 80mg daily .Dose escalation to120mg daily was allowed if well tolerated.
Immune checkpoint inhibitor (physician decided) .
Eliglustat+Immune checkpoint inhibitorDrug
Also called Eliglustat(Cerdelga)
Eliglustat 84mg will be administered twice daily in the first 14 days and the following every other week.
Immune checkpoint inhibitor (physician decided) .
Eliglustat+Immune checkpoint inhibitor +RegorafenibDrug
Also called Regorafenib(Stivarga), Eliglustat(Cerdelga)
Eliglustat 84mg will be administered twice daily in the first 14 days and the following every other week.
Immune checkpoint inhibitor (physician decided) .
Regorafenib orally 80mg daily .Dose escalation to 120mg daily was allowed if well tolerated.
| Study group | Role | What they receive |
|---|---|---|
| Arm A:Regorafenib+Immune checkpoint inhibitor | Active comparator | Regorafenib orally 80mg daily for 21 days (3 weeks on, 1 week off, 4 weeks as a cycle).Dose escalation to 120mg daily was allowed if well tolerated.
until:unacceptable toxicity occurred or disease progression.
Immune checkpoint inhibitor (physician decided) will be administered intravenously on day 5 every 3 weeks. For patients who still benefit from the trial, immune checkpoint inhibitor will be administered every 3 week to 96 weeks. Receives: Drug: Regorafenib+Immune checkpoint inhibitor |
| Arm B:Eliglustat+Immune checkpoint inhibitor | Experimental | Eliglustat 84mg will be administered twice daily in patients who are CYP2D6 extensive metabolizers (EMs), or intermediate metabolizers (IMs), in the first 14 days and the following every other week until 24 weeks. For patients who still benefit from the trial, eliglustat 84mg will be administered twice daily every other week to 96 weeks.
Immune checkpoint inhibitor (physician decided) will be administered intravenously on day 5 every 3 weeks. For patients who still benefit from the trial, immune checkpoint inhibitor will be administered every 3 week to 96 weeks. Receives: Drug: Eliglustat+Immune checkpoint inhibitor |
| Arm C:Eliglustat+Immune checkpoint inhibitor+Regorafenib | Experimental | Eliglustat 84mg will be administered twice daily in patients who are CYP2D6 extensive metabolizers (EMs), or intermediate metabolizers (IMs), in the first 14 days and the following every other week until 24 weeks. For patients who still benefit from the trial, eliglustat 84mg will be administered twice daily every other week to 96 weeks.
Immune checkpoint inhibitor (physician decided) will be administered intravenously on day 5 every 3 weeks. For patients who still benefit from the trial, immune checkpoint inhibitor will be administered every 3 week to 96 weeks.
Regorafenib orally 80mg daily for 21 days (3 weeks on, 1 week off, 4 weeks as a cycle).Dose escalation to 120mg daily was allowed if well tolerated.
until:unacceptable toxicity occurred or disease progression. Receives: Drug: Eliglustat+Immune checkpoint inhibitor +Regorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Objective response rate includes complete response and partial response defined by investigators according to RECIST 1.1or iRECIST criteria.
Measured: Up to 120 days after the last dose of study drugs
Secondary outcomes (2)
Progression Free Survival (PFS)
Time from the date of first administration of the study drug to disease progression or death from any cause (any earliest date).
Measured: Up to 2 years
Overall Survival (OS)
Time from the date of first administration of the study drug to the date of death.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Mar 2029 (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 Chinese PLA General HospitalThe 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han weidong, Chinese PLA General Hospital
- Investigators
- Weidong Han, Ph.D, Principal investigator, Biotherapeutic Department, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558773
- Sponsor's protocol ID
- CHN-PLAGH-BT-088
- Status last verified
- Feb 2026
- First submitted
- 13 Aug 2024
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GSL Synthetase Inhibitor in Combination With Immune Checkpoint Inhibitor and/or Regorafenib for Patients With Advanced/Metastatic pMMR/MSS Colorectal Cancer:an Open-Label, Randomized,Phase II Study
- ClinicalTrials.gov ID
- NCT06558773
- Acronym / sponsor ID
- CHN-PLAGH-BT-088
- Conditions
- Colorectal Cancer
- Keywords
- GSL synthetase inhibitor, Immune checkpoint inhibitor, regorafenib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 19 Aug 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.
In this single-center,open-label, randomized, phase II study, the efficacy and feasibility of GSL synthetase inhibitor in combination with immune checkpoint inhibitor and/or regorafenib therapeutic regimen will be evaluated in patients with advanced/metastatic proficient mismatch repair/microsatellite stable (pMMR/MSS) colorectal cancer (CRC).In this clinical trial, a total of 120 eligible patients were stratified randomly (with/without liver metastases) assigned to the 3 arms in a 1:1:1 ratio: comparator group-arm A (Regorafenib+Immune checkpoint inhibitor) ,experimental group-arm B (Eliglustat+Immune checkpoint inhibitor) and experimental group-arm C (Eliglustat+Immune checkpoint inhibitor+Regorafenib).It aims to: 1).assess the antitumor effects of GSL synthetase inhibitor in combination with immune checkpoint inhibitor and/or regorafenib;2).evaluate the immunological or clinical predictive biomarkers for efficacy and toxicity; 3).detect the transformation of tumor microenvironment (TME) and dynamic changes of immune cells in peripheral blood after the treatment with GSL synthetase inhibitor in combination with immune checkpoint inhibitor and/or regorafenib.
Detailed description
Immunotherapy has achieved significant therapeutic effect in DNA mismatch repair-deficient or microsatellite instability-high (dMMR/MSI-H) metastatic colorectal cancer(mCRC). Distinct from those with dMMR/MSI-H mCRC, isolated immunotherapy has proven to be almost ineffective for patients with pMMR/MSS type mCRC,which indicating a worse prognosis.
Previous work has established that the TME is distinct between MSI-H and MSS CRC. Therapeutic combinations of targeted therapy and immunotherapy,such as regorafenib combined with programmed death 1(PD-1) monoclonal antibody ,which can alter the TME and successfully promote favorable immune modulation has attracted extensive attention.Based on the small sample clinical trial results of other regorafenib combined with anti-PD-1 monoclonal antibody , the overall ORR is between 0% and 33.3%, the ORR for non-liver metastases is between 20% and 50%, and the ORR for liver metastases is between 0% and 15%,demonstrating limited clinical benefit.
Besides TME,another important reason is that tumor cells often escape from immune surveillance by downregulating one or multiple molecules critical in human leukocyte antigen (HLA ) antigen presentation. As a consequence, options that could restore HLA antigen presentation may augment immune checkpoint inhibitor-mediated immune responses.
Abnormal expression of glycosphingolipid (GSL) synthetase is a basic and specific characteristic of most tumors and tumor microenvironment, such as Globo H Ceramide, which is overexpressed in multiple epithelial-derived tumors. Several studies also reported that GSL synthetase was overexpressed in chemotherapy-resistant tumors. Eliglustat is an orally GlcCer synthase inhibitor, which is approved for treating Type-1 Gaucher disease. However, one most recent study reveals that it could inhibit glycosphingolipids synthesis and restore HLA antigen presentation, and transforming the immunogenicity of tumor cells.The investigators has demonstrated the excellent safety and efficacy of the combination of Eliglustat and immune checkpoint inhibitor in advanced/ metastatic solid tumors and r/r hematological malignancies,especially in pMMR/MSS mCRC (even with liver metastases).
Based on the above reasons, we designed this open-label, randomized,phase II study to observe the efficacy and feasibility of the GSL synthetase inhibitor in combination with immune checkpoint Inhibitor and/or regorafenib for patients with advanced/metastatic pMMR/MSS CRC and strive to provide a high-level evidence-based basis for combination therapy regimen for these patients. A total of 120 advanced/metastatic pMMR/MSS CRC patients were stratified randomly (with/without liver metastases) assigned to the 3 arms in a 1:1:1 ratio: comparator group-Arm A (Regorafenib+Immune checkpoint inhibitor),experimental group-Arm B(Eliglustat+Immune checkpoint inhibitor) and experimental group-Arm C (Eliglustat+Immune checkpoint inhibitor+Regorafenib).The primary objective of this study is to assess the efficacy and feasibility of the above two experimental groups.The exploratory objectives are to evaluate the immunological or clinical predictive biomarkers for efficacy and toxicity, transformation of tumor microenvironment and dynamic changes of immune cells in peripheral blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A:Regorafenib+Immune checkpoint inhibitor | Active comparator | Drug: Regorafenib+Immune checkpoint inhibitorRegorafenib orally 80mg daily for 21 days (3 weeks on, 1 week off, 4 weeks as a cycle).Dose escalation to 120mg daily was allowed if well tolerated. until:unacceptable toxicity occurred or disease progression. Immune checkpoint inhibitor (physician decided) will be administered intravenously on day 5 every 3 weeks. For patients who still benefit from the trial, immune checkpoint inhibitor will be administered every 3 week to 96 weeks. |
| Arm B:Eliglustat+Immune checkpoint inhibitor | Experimental | Drug: Eliglustat+Immune checkpoint inhibitorEliglustat 84mg will be administered twice daily in patients who are CYP2D6 extensive metabolizers (EMs), or intermediate metabolizers (IMs), in the first 14 days and the following every other week until 24 weeks. For patients who still benefit from the trial, eliglustat 84mg will be administered twice daily every other week to 96 weeks. Immune checkpoint inhibitor (physician decided) will be administered intravenously on day 5 every 3 weeks. For patients who still benefit from the trial, immune checkpoint inhibitor will be administered every 3 week to 96 weeks. |
| Arm C:Eliglustat+Immune checkpoint inhibitor+Regorafenib | Experimental | Drug: Eliglustat+Immune checkpoint inhibitor +RegorafenibEliglustat 84mg will be administered twice daily in patients who are CYP2D6 extensive metabolizers (EMs), or intermediate metabolizers (IMs), in the first 14 days and the following every other week until 24 weeks. For patients who still benefit from the trial, eliglustat 84mg will be administered twice daily every other week to 96 weeks. Immune checkpoint inhibitor (physician decided) will be administered intravenously on day 5 every 3 weeks. For patients who still benefit from the trial, immune checkpoint inhibitor will be administered every 3 week to 96 weeks. Regorafenib orally 80mg daily for 21 days (3 weeks on, 1 week off, 4 weeks as a cycle).Dose escalation to 120mg daily was allowed if well tolerated. until:unacceptable toxicity occurred or disease progression. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥18 years old and ≤75 years old.
- Histologically confirmed diagnosis of unresectable locally advanced, recurrent or metastatic colorectal cance have failed at least two lines of prior treatment.
- Tumor tissues were identified as pMMR by immunohistochemistry (IHC) method or MSS by polymerase chain reaction (PCR).
- CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs).
- Eastern Cooperative Oncology Group (ECOG) performance status score≤2 and Estimated life expectancy of more than 3 months.
Key exclusion criteria (18 listed)
- Participants with dMMR /MSI-H colorectal cancer.
- CYP2D6 ultra-rapid metabolizers (URMs).
- Active, known or suspected autoimmune diseases.
- The patients is taking a CYP2D6 inhibitor and/or concomitantly with a strong or moderate CYP3A inhibitor.
- Subjects are being treated with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment.
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 |
|---|---|---|
| Regorafenib+Immune checkpoint inhibitorAlso: Regorafenib(Stivarga)Regorafenib orally 80mg daily .Dose escalation to120mg daily was allowed if well tolerated. Immune checkpoint inhibitor (physician decided) . | Drug | Arm A:Regorafenib+Immune checkpoint inhibitor |
| Eliglustat+Immune checkpoint inhibitorAlso: Eliglustat(Cerdelga)Eliglustat 84mg will be administered twice daily in the first 14 days and the following every other week. Immune checkpoint inhibitor (physician decided) . | Drug | Arm B:Eliglustat+Immune checkpoint inhibitor |
| Eliglustat+Immune checkpoint inhibitor +RegorafenibAlso: Regorafenib(Stivarga), Eliglustat(Cerdelga)Eliglustat 84mg will be administered twice daily in the first 14 days and the following every other week. Immune checkpoint inhibitor (physician decided) . Regorafenib orally 80mg daily .Dose escalation to 120mg daily was allowed if well tolerated. | Drug | Arm C:Eliglustat+Immune checkpoint inhibitor+Regorafenib |
Primary outcome
Objective response rate (ORR)
Time frame: Up to 120 days after the last dose of study drugs
Objective response rate includes complete response and partial response defined by investigators according to RECIST 1.1or iRECIST criteria.
2 secondary outcomes
Progression Free Survival (PFS)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
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 11 Feb 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.
Weidong Han, Ph.D principal investigator
Biotherapeutic Department, Chinese PLA General Hospital
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 Regorafenib+Immune checkpoint inhibitor, Eliglustat+Immune checkpoint inhibitor and Eliglustat+Immune checkpoint inhibitor +Regorafenib in people with Colorectal Cancer, run by Chinese PLA General Hospital 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 12 inclusion and 18 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 11 Feb 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 Weidong Han, Ph.D (010-66937231, hanwdrsw@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Up to 120 days after the last dose of study drugs). 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 11 Feb 2026.