Real-World Study of Chidamide Combined With PD-(L)1 Inhibitors and Anti-Angiogenic Therapy for Advanced MSS-Type Colorectal Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Chidamide, Tucidinostat; PD-1/PD-L1 inhibitor or double antibodies; Bevacizumab or tyrosine kinase inhibitors

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Aiping Zhou, PHD; Phone Number: 010-87788800; Email: zhouap1825@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Advanced MSS-Type Colorectal Cancer

Description

Inclusion Criteria:

• Age ≥18 years, male or female.

Histologically confirmed advanced colorectal cancer with microsatellite stable (MSS)/proficient mismatch repair (pMMR) status confirmed by immunohistochemistry (IHC) or molecular testing.

No restriction on prior immunotherapy or combined anti-angiogenic agents (e.g., bevacizumab or small-molecule TKIs).

ECOG performance status of 0-2.

At least one post-treatment efficacy evaluation.

Life expectancy ≥3 months.

Chidamide treatment duration >3 weeks

Exclusion Criteria:

- 1. Malignancies in other organs or systems, except for cured basal cell/squamous cell skin cancer or cervical carcinoma.

2. Severe comorbidities that may interfere with efficacy or safety analysis. 3. Conditions deemed unsuitable for study inclusion by the investigator.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
TTF	24 months

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: February 28, 2025
• First Submitted That Met QC Criteria: February 28, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 28, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab; Immune Checkpoint Inhibitors; Tyrosine Kinase Inhibitors; Antibodies
• Other Study ID Numbers: CSIIT-Q99

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No