Phase III Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients
NCT Number: NCT06497985
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Colorectal Cancer
Interventions: DRUG: Tucidinostat|DRUG: Sintilimab|DRUG: Bevacizumab|DRUG: Fruquintinib
Sponsor: Chipscreen Biosciences, Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 430
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2028-09-30

Summary:
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.

Primary Outcome Measures: Overall Survival (OS), From randomization to the date of death from any cause., Up to approximately 2 years
Secondary Outcome Measures: Progression Free Survival (PFS), PFS assessed by investigator per RECIST v1.1, measured from the date of randomization until progression or death, whichever occurs first., Up to approximately 2 years|Overall response rate (ORR), Proportion of participants who achieved complete response (CR) or partial response (PR) assessed by investigator according to RECIST v1.1., Up to approximately 2 years|Duration of response (DOR), From the first occurrence of PR or CR until the date of first documented progression according to RECIST 1.1, or death, whichever occurs first., Up to approximately 2 years|Disease control rate (DCR), Proportion of participants who achieved CR or PR, or stable disease (SD) assessed by investigator according to RECIST v1.1., Up to approximately 2 years|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life Scale Score, EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and global health status/QOL scale.Change from baseline in the EORTC QLQ-C30 Global Health Status/Quality of Life Scale scores will be presented., Up to approximately 2 years|Change From Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Health Utility Index Scores, The EQ-5D-5L is a self-reported health status questionnaire that consisted of 2 components: health state profile and optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: no problem, slight problem, moderate problem, severe problem, and extreme problem. Change from baseline in health utility index scores will be presented., Up to approximately 2 years|Change From Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score, EQ-5D-5L consisted of 2 components: health state profile and optional VAS. The VAS records the respondent's self-rated health on a vertical visual analogue scale. The VAS 'thermometer' has endpoints of 100 (Best imaginable health state) at the top and 0 (Worst imaginable health state) at the bottom. Change from baseline in EQ-5D-5L VAS scores will be presented., Up to approximately 2 years|Safety and Tolerability, Number of Participants Who Experience an Adverse Event (AE) assessed by CTCAE v5.0., Up to approximately 2 years|Plasma concentrations of tucidinostat, Plasma samples were collected from the participants at the defined time points. Plasma concentrations were measured using a validated, specific, and sensitive method., Up to approximately 6 months