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.
This is a randomised, open-label, multicenter phase III study evaluating the efficacy and safety of tucidinostat in combination with sintilimab and bevacizumab versus fruquintinib monotherapy in MSS/pMMR colorectal cancer patients. 430 patients will be randomised (1:1) to receive tucidinostat in combination with sintilimab and bevacizumab (experimental arm) or fruquintinib monotherapy (control arm).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
430
30mg orally BIW
200 mg intravenously (IV) Q3W
7.5mg/kg intravenously (IV) Q3W
Rui-Hua Xu
Guangzhou, Guangdong, China
RECRUITINGOverall Survival (OS)
From randomization to the date of death from any cause.
Time frame: Up to approximately 2 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
5mg orally QD
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 2 years
Safety and Tolerability
Number of Participants Who Experience an Adverse Event (AE) assessed by CTCAE v5.0.
Time frame: 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.
Time frame: Up to approximately 6 months