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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Not yet enrolling

Conditions: Colorectal Cancer

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

Study type: Observational

Funder types: Other

Identifiers

NCT06858956

CSIIT-Q99

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.