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GSL Synthetase Inhibitor Plus Immune Checkpoint Inhibitor and/or Regorafenib in Previously Treated pMMR/MSS CRC.

StatusRecruiting
PhasePhase 2
Started2026-03-01
View on ClinicalTrials.gov ↗

Amendment history

2026-02-09
Not Yet Recruiting→Recruiting Study Status, Study Description, Arms and Interventions, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-08-31→2027-03-01
Completion date2027-08-31→2029-03-31
Start date2024-09-01→2026-03-01
InterventionsEliglustat+Immune checkpoint inhibitor (Drug), Eliglustat+Immune checkpoint inhibitor+Regorafenib (Drug), Regorafenib+Immune checkpoint…→Eliglustat+Immune checkpoint inhibitor (Drug), Eliglustat+Immune checkpoint inhibitor +Regorafenib (Drug), Regorafenib+Immune checkpoint…
Study description+2 characters
[...] liver metastases) assigned to the 3 arms in a 1:1:1 ratio: experimentalcomparator group-Arm A (EliglustatRegorafenib+Immune checkpoint inhibitor+Regorafenib),experimental group-Arm B(Eliglustat+Immune checkpoint inhibitor) and comparatorexperimental group-Arm C (RegorafenibEliglustat+Immune checkpoint inhibitor+Regorafenib).The primary objective of this study is to assess the effic [...]
Study sitesdetails revised at 1 of 1 site
2024-08-19
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v1
Eligibility criteria+42 characters
[...] ntermediate 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 l [...]
Study description+61 characters
[...] therapy and immunotherapy,such as regorafenib combined with programmed death 1(PD-1) monoclonal antibody ,which can alter the TME and successfully promote favorable [...] n.Based on the small sample clinical trial results of other regifenibregorafenib combined with anti-PD-1 monoclonal antibody drugs, the overall ORR is between 0% and 33.3%, the ORR for non-l [...] nce by downregulating one or multiple molecules critical in human leukocyte antigen (HLA ) antigen presentation. As a consequence, options that could [...] ntation, and transforming the immunogenicity of tumor cells.OurThe previous phase I studyinvest [...] [...]
2024-08-15
Original filing
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.
Trial Details
NCT Number NCT06558773
Lead Sponsor Chinese PLA General Hospital
Conditions Colorectal Cancer
Enrollment 120 participants
Start Date 2026-03-01
Primary Completion 2027-03-01 (estimated)
Study Completion 2029-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-11