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Not yet recruitingNCT06858956Updated Mar 5, 2025

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

An observational study in Colorectal Cancer, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-05.

Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Observational

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
200
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Colorectal Cancer
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In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 200 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 373 studies on the registry; 270 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Advanced MSS-Type Colorectal Cancer

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

Exclusion Criteria:

    1. Malignancies in other organs or systems, except for cured basal cell/squamous cell skin cancer or cervical carcinoma.
  1. Severe comorbidities that may interfere with efficacy or safety analysis. 3. Conditions deemed unsuitable for study inclusion by the investigator.
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No

Interventions

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

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

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What researchers measure

Primary outcomes

  1. TTF

    Time frame: 24 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06858956
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Responsible party
AIPING ZHOU (Doctor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences) — Principal investigator
First posted
Mar 5, 2025
Start date
Mar 1, 2025 (estimated)
Primary completion
May 31, 2025 (estimated)
Completion
May 31, 2026 (estimated)
Last update
Mar 5, 2025

Study contacts

Aiping Zhou, PHD
Contact
zhouap1825@126.com
010-87788800

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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