A Real-world Study of Chidamide in Combination with PD-1/PD-L1 Antibodies and Anti-angiogenic Agents in Advanced MSS Colorectal Cancer

Not yet recruiting

• Conditions: Colorectal Cancer Metastatic
• Interventions: Drug: Chidamide, Tucidinostat; PD-1/PD-L1 inhibitor or double antibodies; Bevacizumab or tyrosine kinase inhibitors

• Registration Number: NCT06682247
• Lead Sponsor: Feng Wang

Brief Summary

This is an observational , multicenter, real-world study aimed at evaluating the efficacy and safety of the combination of immune checkpoint inhibitors, chidamide and antiangiogenic agents in Microsatellite Stable advanced colorectal cancer patients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-07
• Study First Submitted QC: 2024-11-07
• Last Update Submitted: 2024-11-07
• Study First Posted: 2024-11-11
• Last Update Posted: 2024-11-11
• Study Start: 2024-11-15
• Primary Completion: 2025-06-15
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Aged≥18 years
2. Histology-confirmed metastatic CRC (mCRC);
3. ECOG 0~2
4. At least one efficacy evaluation
5. Life expectancy of at least 3 months.

Exclusion Criteria

1. Lack of follow-up data.
2. Chidamide stopped after less than two cycles.
3. Serious comorbidities that interfere with the efficacy or safety analysis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
chidamide + PD-1/PD-L1 inhibitors +Bevacizumab or tyrosine kinase inhibitors	Chidamide, Tucidinostat; PD-1/PD-L1 inhibitor or double antibodies; Bevacizumab or tyrosine kinase inhibitors	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival(PFS)	2 years

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate（ORR）	2 years
Clinical Benefit Rate (CBR)	2 years
Disease Control Rate （DCR）	2 years
Overall survival (OS)	2 years