Clinical Study on the Expression of PHGDH and Its Prognostic Value in Colorectal Cancer Patients Receiving Immunotherapy

March 27, 2026 updated by: Xuelei Ma MD, West China Hospital
This study aims to evaluate the expression characteristics of PHGDH in tumor tissues based on the clinical data and pathological tissue samples of colorectal cancer patients who have previously received immunotherapy, and to analyze its correlation with patients' clinical features, immunotherapy efficacy, and survival prognosis, providing a basis for clarifying the clinical relevance of PHGDH.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This is a single-center, retrospective cohort study. The study population consists of patients with histologically confirmed colorectal adenocarcinoma who initiated immune checkpoint inhibitor therapy at [Your Hospital Name] between June 2018 and December 2025. Participants will be categorized into PHGDH-high and PHGDH-low groups based on the expression level of PHGDH protein in pre-treatment tumor tissue (assessed by immunohistochemistry). The primary objective is to compare the effectiveness of immunotherapy (e.g., progression-free survival) between the two groups.

Description

Inclusion Criteria:

  1. Patients with histologically confirmed colorectal adenocarcinoma.
  2. Initiated treatment with immune checkpoint inhibitors (at least one cycle) between June 1, 2018 and December 31, 2025.
  3. Availability of pre-treatment archival tumor tissue (FFPE block or slides) for PHGDH immunohistochemistry testing.
  4. Have evaluable baseline radiographic images (CT or MRI) prior to immunotherapy.
  5. Sufficient medical records for survival follow-up data extraction.

Exclusion Criteria:

  1. Unavailability of adequate tumor tissue for PHGDH expression analysis.
  2. Permanently discontinued immunotherapy prior to the first scheduled radiological response assessment.
  3. History of other active malignancies within the past 5 years (except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix).
  4. Insufficient clinical documentation to determine the primary outcome (e.g., progression-free survival).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PHGDH High
Other: No intervention
No therapeutic or experimental intervention was administered in this study. Participants were assigned to the PHGDH-high and PHGDH-low cohorts according to PHGDH expression in tumor tissues for observational analysis of clinical outcomes and treatment response.
PHGDH Low
Other: No intervention
No therapeutic or experimental intervention was administered in this study. Participants were assigned to the PHGDH-high and PHGDH-low cohorts according to PHGDH expression in tumor tissues for observational analysis of clinical outcomes and treatment response.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Assessed at 3 months after initiation of immunotherapy.
Proportion of participants achieving a complete response (CR) or partial response (PR) per RECIST v1.1 criteria.
Assessed at 3 months after initiation of immunotherapy.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Time Frame: From the start of treatment until the first progression event or the end of follow-up (assessed up to 36 months).
Time from the first dose of immune checkpoint inhibitor therapy to radiographic disease progression as per RECIST v1.1 criteria or death from any cause, whichever occurs first.
Time Frame: From the start of treatment until the first progression event or the end of follow-up (assessed up to 36 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Actual)

January 1, 2026

Study Completion (Actual)

January 1, 2026

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

March 27, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Approval No. 149 (2026)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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