OncoMatch/Clinical Trials/NCT06497985
A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients
Is NCT06497985 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Tucidinostat and Sintilimab for colorectal cancer.
Treatment: Tucidinostat · Sintilimab · Bevacizumab · Fruquintinib — A randomised, open-label, multicenter phase III study to evaluate the efficacy and safety of tucidinostat in combination with sintilimab and bevacizumab versus fruquintinib monotherapy in MSS/pMMR colorectal cancer patients.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MMR proficient
Have confirmed MSS or MSI-L, or pMMR
Required: MSI microsatellite stable
Have confirmed MSS or MSI-L, or pMMR
Required: MSI microsatellite instability-low
Have confirmed MSS or MSI-L, or pMMR
Allowed: KRAS mutant
KRAS status must have been previously determined (mutant or wild-type)
Allowed: KRAS wild-type
KRAS status must have been previously determined (mutant or wild-type)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: fluoropyrimidine
previously treated and has shown disease progression or could not tolerate standard treatment, which must include fluoropyrimidine, irinotecan and oxaliplatin
Must have received: irinotecan
previously treated and has shown disease progression or could not tolerate standard treatment, which must include fluoropyrimidine, irinotecan and oxaliplatin
Must have received: oxaliplatin
previously treated and has shown disease progression or could not tolerate standard treatment, which must include fluoropyrimidine, irinotecan and oxaliplatin
Cannot have received: HDAC inhibitor
Prior use of HDAC inhibitor
Cannot have received: PD-1 inhibitor
Received prior therapies targeting PD-1, PD-L1, CTLA4, or any other immune checkpoint pathway
Cannot have received: PD-L1 inhibitor
Received prior therapies targeting PD-1, PD-L1, CTLA4, or any other immune checkpoint pathway
Cannot have received: CTLA-4 inhibitor
Received prior therapies targeting PD-1, PD-L1, CTLA4, or any other immune checkpoint pathway
Cannot have received: immune checkpoint inhibitor
Received prior therapies targeting PD-1, PD-L1, CTLA4, or any other immune checkpoint pathway
Cannot have received: small-molecule tyrosine kinase inhibitor of VEGF receptors
Prior use of small-molecule tyrosine kinase inhibitor of VEGF receptors
Lab requirements
Blood counts
Adequate organ function
Kidney function
Adequate organ function
Liver function
Adequate organ function
Adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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