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Study identifier: NCT06930118 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

The Aim of This Study is to Assess the Efficacy and Safety of Chidamide, Regorafenib in Combination With Iparomlimab and Tuvonralimab for the Treatment of Advanced Colorectal Cancer in Third-line Therapy and Subsequent Lines.

Condition: Advanced Colorectal Cancer in the Third-line Treatment and Beyond · pMMR/MSS Advanced Colorectal Cancer  ·  Sponsor: Shanghai Changzheng Hospital

PhasePhase 2
Planned participants60
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Patients with advanced colorectal cancer, particularly those of the pMMR/MSS type, exhibit suboptimal therapeutic responses in the third-line and subsequent treatments. The efficacy of the existing standard treatment regimens is highly restricted. In the CORRECT study, the median overall survival (OS) of regorafenib was 6.4 months, the median progression-free survival (PFS) was 1.9 months, and the objective response rate (ORR) was 1%. In the CONCUR study targeting the Asian population, the median OS of the regorafenib group was 8.8 months, the median PFS was 3.2 months, and the ORR was 4%. In the FRESCO study, the median OS of fruquintinib was 9.3 months, the median PFS was 3.7 months, and the ORR was 4.7%. In the TERRA study, the median OS of trifluridine/tipiracil (TAS-102) was 7.8 months, the median PFS was 2.0 months, and the ORR was 1.1%. The SUNLIGHT study explored the combined treatment modality of TAS-102 plus bevacizumab, where the median OS of the combined regimen was 10.8 months, the median PFS was 5.6 months, and the ORR was 6.1%. Evidently, the therapeutic efficacy of advanced colorectal cancer in the third-line and beyond has plateaued. In recent years, fundamental research has discovered that epigenetic regulation significantly synergizes with anti-angiogenesis and immune checkpoint inhibition therapy. Small-scale clinical explorations have also indicated favorable efficacy and clinical prospects, warranting further investigation. Hence, we contemplate employin…

This description comes directly from the study's public registry record.

Talk to the study team

Zhan Wang  ·  86 21 66540109-8007  ·  13916229609@139.com

Always discuss trial participation with your own doctor first.

Locations (1)

Department of Medical Oncology, Second Affiliated Hospital of Naval Medical UniversityShanghai, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT06930118