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

NCT06682247 | Not Yet Recruiting

• 1 other identifier: CSIIT-Q88
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Progression-free survival(PFS)

  2 years

Secondary Outcomes (4)

• Objective Response Rate（ORR）

  2 years

• Clinical Benefit Rate (CBR)

  2 years

• Disease Control Rate （DCR）

  2 years

• Overall survival (OS)

  2 years

Study Arms (1)

chidamide + PD-1/PD-L1 inhibitors +Bevacizumab or tyrosine kinase inhibitors

Drug: Chidamide, Tucidinostat; PD-1/PD-L1 inhibitor or double antibodies; Bevacizumab or tyrosine kinase inhibitors

Interventions

Chidamide, Tucidinostat; PD-1/PD-L1 inhibitor or double antibodies; Bevacizumab or tyrosine kinase inhibitors DRUG

Chidamide, Tucidinostat; PD-1/PD-L1 inhibitor or double antibodies; Bevacizumab or tyrosine kinase inhibitors

chidamide + PD-1/PD-L1 inhibitors +Bevacizumab or tyrosine kinase inhibitors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

advanced/metastatic MSS colorectal cancer patients

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Feng Wang: lead

MeSH Terms

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; Bevacizumab; Tyrosine Kinase Inhibitors

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

feng wang

CONTACT

020-87343088; wangfeng@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sun Yat-sen University Cancer Center

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: November 15, 2024
• Primary Completion: June 15, 2025
• Study Completion: December 31, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-11