NCT06980350

Brief Summary

A novel evaluation model for identifying complete response following neoadjuvant immune checkpoint inhibitor therapy therapy in patients with dMMR colon cancer was developed to validated its efficacy in two independent cohorts, and to assessed its feasibility for W\&W strategy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 20, 2025

Completed
Last Updated

July 29, 2025

Status Verified

May 1, 2025

Enrollment Period

5 years

First QC Date

May 12, 2025

Last Update Submit

July 24, 2025

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Complete response (CR)

    Complete response: Pathological complete response and clinical complete response

    1 year

Interventions

PD-1 InhibitorsDRUG

Patients received at least two doses of anti-PD-1 immunotherapy in a neoadjuvant setting.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with dMMR colon cancer receiving neoICI therapy

You may qualify if:

  • pathologically confirmed colon adenocarcinoma;
  • immunohistochemistry testing as dMMR tumors;
  • received at least two doses of anti-PD-1 immunotherapy in a neoadjuvant setting.
  • received radical surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesAntineoplastic Agents, ImmunologicalAntineoplastic AgentsTherapeutic Uses

Study Officials

  • Peirong Ding, M.D.

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Department of Colorectal Surgery

Study Record Dates

First Submitted

May 12, 2025

First Posted

May 20, 2025

Study Start

July 1, 2018

Primary Completion

June 30, 2023

Study Completion

December 30, 2024

Last Updated

July 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)