OncoMatch/Clinical Trials/NCT06558773
GSL Synthetase Inhibitor Plus Immune Checkpoint Inhibitor and/or Regorafenib in Previously Treated pMMR/MSS CRC.
Is NCT06558773 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Regorafenib+Immune checkpoint inhibitor and Eliglustat+Immune checkpoint inhibitor for colorectal cancer.
Treatment: Regorafenib+Immune checkpoint inhibitor · Eliglustat+Immune checkpoint inhibitor · Eliglustat+Immune checkpoint inhibitor +Regorafenib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Required: CYP2D6 extensive metabolizer
CYP2D6 extensive metabolizers (EMs)
Required: CYP2D6 intermediate metabolizer
CYP2D6 intermediate metabolizers (IMs)
Required: CYP2D6 poor metabolizer
CYP2D6 poor metabolizers (PMs)
Excluded: CYP2D6 ultra-rapid metabolizer
CYP2D6 ultra-rapid metabolizers (URMs)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06558773 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require CYP2D6?
Yes, CYP2D6 extensive metabolizer is a required biomarker for enrollment.
Does this trial require CYP2D6?
Yes, CYP2D6 intermediate metabolizer is a required biomarker for enrollment.
Does this trial require CYP2D6?
Yes, CYP2D6 poor metabolizer is a required biomarker for enrollment.
Are patients with CYP2D6 alterations eligible?
No. CYP2D6 ultra-rapid metabolizer is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages