Actively Recruiting
GSL Synthetase Inhibitor Plus Immune Checkpoint Inhibitor and/or Regorafenib in Previously Treated pMMR/MSS CRC.
Led by Chinese PLA General Hospital · Updated on 2026-02-11
120
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GSL Synthetase Inhibitor Plus Immune Checkpoint Inhibitor and/or Regorafenib in Previously Treated pMMR/MSS CRC.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years old
- Histologically confirmed unresectable locally advanced, recurrent or metastatic colorectal cancer
- Tumor identified as proficient mismatch repair (pMMR) or microsatellite stable (MSS)
- CYP2D6 extensive, intermediate, or poor metabolizers
- ECOG performance status of 0 to 2
- Estimated life expectancy over 3 months
- At least one measurable lesion by RECIST version 1.1
- Fresh or recent (within 6 months) tumor tissue samples available; willing to undergo tumor biopsy
- Adequate organ function confirmed within 2 weeks prior to first study drug dose
- Completed previous cancer treatments more than 4 weeks before enrollment with recovery to grade 1 or less toxicity
- Previous treatment with anti-PD-1/PD-L1 or CTLA-4 inhibitors allowed
- Negative pregnancy test for women of childbearing potential; agreement to use effective contraception during treatment and for 1 year after
- Ability to understand and sign informed consent
You will not qualify if you...
- Diagnosis of deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer
- CYP2D6 ultra-rapid metabolizers
- Active, known, or suspected autoimmune diseases
- Use of CYP2D6 inhibitors or strong/moderate CYP3A inhibitors
- Treatment with corticosteroids (>10 mg prednisone daily) or immunosuppressants within 14 days before enrollment
- History of severe hypersensitivity to monoclonal antibodies
- Allergy or intolerance to study drug components
- Known brain metastases or active central nervous system involvement (except treated stable CNS metastases)
- Uncontrolled illnesses including infections, heart failure, unstable angina, significant arrhythmias, psychiatric or social conditions limiting study compliance
- Positive HIV or AIDS diagnosis
- Other cancers within 3 years except certain treated early-stage cancers
- Major surgery or trauma within 28 days prior to enrollment or unresolved major side effects
- Vaccination within 30 days before enrollment
- Active bleeding or bleeding tendencies; recent life-threatening bleeding
- Uncontrolled hypertension despite treatment
- Pregnant or breastfeeding women
- Participation in other clinical trials or withdrawal within 4 weeks
- Any other condition deemed unsuitable by investigators for trial participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
China
Beijing, Biotherapeutic Department of Chinsese PLA Gereral Hospital, China
Actively Recruiting
Research Team
W
Weidong Han, Ph.D
CONTACT
Y
Yang Liu, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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