NCT05768503

Comparing Chidamide+Sintilimab+Bev With Standard Second-line FOLFIRI+Bev in Advanced MSS/pMMR mCRC

Chidamide+Sintilimab+Bevacizumab Versus Standard Second-Line Therapy of FOLFIRI+Bevacizumab in Subjects With Advanced Microsatellite Stable (MSS/pMMR) Colorectal Cancer Who Have Failed Oxaliplatin-Containing First-Line Therapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, controlled, multicenter phase Ⅲ study to evaluate the therapeutic efficacy and safety of chidamide + sintilimab + bevacizumab versus standard second-line FOLFIRI + bevacizumab therapy in subjects with advanced microsatellite stable colorectal cancer who have failed first-line oxaliplatin-containing standard therapy. The primary purpose is to compare the progression-free survival (PFS) of chidamide + sintilimab + bevacizumab versus standard second-line FOLFIRI + bevacizumab therapy for colorectal cancer, with a planned enrollment of 176 subjects with advanced microsatellite stable colorectal cancer who have failed first-line oxaliplatin-containing standard therapy.

Detailed description

Subjects will be randomized in a 1:1 ratio into either the chidamide + sintilimab + bevacizumab group or the standard second-line FOLFIRI + bevacizumab therapy group. The treatment option for the chidamide + sintilimab + bevacizumab (study group) is 200 mg of sintilimab IV Drip Q3W, 30 mg of chidamide PO BIW, and bevacizumab 7.5 mg/kg IV Drip Q3W, with a maximum treatment duration of 2 years. The treatment option for the standard second-line FOLFIRI + bevacizumab therapy group (control group) is bevacizumab 5 mg/kg IV Drip Q2W, irinotecan 180 mg/m2 IV Drip Q2W, calcium folinate 400 mg/m2 IV Q2W or calcium levofolinate 200 mg/m2 IV Drip Q2W, 5-fluorouracil 400 mg/m2 IV +2400 mg/m2 CIV Q2W, with a maximum treatment duration of 2 years. The primary endpoint of this study is the progression-free survival (PFS), defined as the time from random assignment of the subject to disease progression or death from any cause. All eligible patients will be randomly assigned to either the trial or control group in a 1:1 ratio based on the following stratification factors: Whether the primary focus is located in the right-sided colorectum; Whether bevacizumab has been administered in the first-line treatment.

Conditions

• Metastatic Microsatellite-stable Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Experimental drug	The treatment option for the chidamide + sintilimab + bevacizumab is 200 mg of sintilimab IV Drip Q3W, 30 mg of chidamide PO BIW, and bevacizumab 7.5 mg/kg IV Drip Q3W until loss of clinical benefit or development of intolerable toxicity (whichever occurs first), with a maximum treatment duration of 2 years.
DRUG	Control Rx	The treatment option for the standard second-line FOLFIRI + bevacizumab therapy group is bevacizumab 5 mg/kg IV Drip Q2W, irinotecan 180 mg/m2 IV Drip Q2W, calcium folinate 400 mg/m2 IV Q2W or calcium levofolinate 200 mg/m2 IV Drip Q2W, 5-fluorouracil 400 mg/m2 IV +2400 mg/m2 CIV (infusion 46-48 hr) Q2W until loss of clinical benefit or development of intolerable toxicity (whichever occurs first), with a maximum treatment duration of 2 years.

Timeline

• Start date: 2023-03-01
• Primary completion: 2026-01-01
• Completion: 2027-01-01
• First posted: 2023-03-14
• Last updated: 2023-03-14

Locations

12 sites across 1 country: China