A Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients
NCT06497985 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 430
Last updated 2026-03-19
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.
Conditions
Interventions
- DRUG
-
Tucidinostat
30mg orally BIW
- DRUG
-
Sintilimab
200 mg intravenously (IV) Q3W
- DRUG
-
7.5mg/kg intravenously (IV) Q3W
- DRUG
-
5mg orally QD
Sponsors & Collaborators
-
Chipscreen Biosciences, Ltd.
lead INDUSTRY
Principal Investigators
-
Rui-Hua Xu · Sun Yat-Sen University Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-06
- Primary Completion
- 2028-05-31
- Completion
- 2028-09-30
Countries
- China
Study Locations
More Related Trials
-
Exploring Sintilimab + Bevacizumab + Decitabine for Advanced pMMR/MSS Colorectal Cancer (After 2+ Prior Therapies)
NCT07007767 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC
NCT07085169 ·Status: RECRUITING ·Phase: PHASE2
-
A Study Assessing the Interchangeability Between TRS003 and Bevacizumab® For CRC
NCT05378867 ·Status: UNKNOWN ·Phase: PHASE3
-
Cadonilimab Combined With Fruquintinib and SBRT as Athird-line and Posterior Line Treatment in Patients With MSS CRC
NCT06168786 ·Status: RECRUITING ·Phase: PHASE2
-
Combination Chemotherapy and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
NCT00628810 ·Status: COMPLETED ·Phase: PHASE2
-
Toripalimab Plus Bevacizumab and Chemotherapy as Neoadjuvant Therapy in Advanced MSI-H or dMMR Colorectal Cancer
NCT04988191 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Fruquintinib Plus Capecitabine Versus Bevacizumab Plus Capecitabine as Maintenance Therapy Following First-line Treatment for Metastatic Colorectal Cancer
NCT04733963 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study of Rivoceranib and Trifluridine/Tipiracil for Metastatic Colorectal Cancer (mCRC)
NCT04073615 ·Status: TERMINATED ·Phase: PHASE1
-
An Observational Study of Bevacizumab in Combination With 5-FU-Based Chemotherapy in Chinese Participants With Metastatic Colorectal Cancer
NCT01319877 ·Status: COMPLETED
-
Fruquintinib With PD-1 Inhibitors Versus TAS-102 With Bevacizumab in Late-Line mCRC
NCT06031376 ·Status: COMPLETED
-
Modulation Of The Tumour Microenvironment Using Either Vascular Disrupting Agents or STAT3 Inhibition in Order to Synergise With PD1 Inhibition in Microsatellite Stable, Refractory Colorectal Cancer
NCT03647839 ·Status: COMPLETED ·Phase: PHASE2
-
Envafolimab Combined With Trifluridine/Tipiracil and Bevacizumab in the Treatment of Refractory mCRC.
NCT06060704 ·Status: RECRUITING ·Phase: PHASE2
-
Alternating Treatment With Fruquintinib and Bevacizumab Plus Capecitabine as Maintenance Therapy After First-Line Treatment in Metastatic Colorectal Cancer
NCT05659290 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of Fruquintinib in Combination With Irinotecan and Capecitabine for the Second-line Treatment of Patients
NCT06169202 ·Status: RECRUITING
-
Sequential Treatment Strategy for Metastatic Colorectal Cancer
NCT01878422 ·Status: COMPLETED ·Phase: PHASE3
-
Tislelizumab Combined With Fruquintinib for Metastatic pMMR/MSS Colorectal Cancer
NCT05690035 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Study Combining mFOLFOX6 With Tivozanib or Bevacizumab in Patients With Metastatic Colorectal Cancer as First Line Therapy
NCT01478594 ·Status: COMPLETED ·Phase: PHASE2
-
Panitumumab and Chemotherapy in Patients With Advanced Colorectal Cancer After Prior Therapy With Bevacizumab
NCT01814501 ·Status: COMPLETED ·Phase: PHASE2
-
Trifluridine/Tipiracil Plus Bevacizumab Versus Trifluridine/Tipiracil Monotherapy in Refractory Metastatic Colorectal Cancer
NCT05869097 ·Status: COMPLETED
-
A Study of 1018 Immunostimulatory Sequence (ISS) Administered With Irinotecan and Cetuximab to Treat Patients With Previously Treated Metastatic Colorectal Cancer
NCT00403052 ·Status: TERMINATED ·Phase: PHASE1
-
Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer
NCT06856187 ·Status: RECRUITING ·Phase: PHASE2
-
Chemotherapy Plus Bevacizumab and Anti-PD-1 Followed by Induction Therapy of Chemotherapy Plus Bevacizumab
NCT06415851 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Bevacizumab-containing Regimen for Metastatic Colorectal Cancer Failed to Cytotoxic Treatment
NCT02226289 ·Status: UNKNOWN ·Phase: PHASE2
-
Sintilimab and Chidamide in Combination With or Without IBI305 in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma
NCT04724239 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer
NCT05609370 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2