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OpenTrials
Completed

NCT Number: NCT07508046

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

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.

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Key information

Conditions

Colo-rectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Observational

Primary location

West China Hospital

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unavailability of adequate tumor tissue for PHGDH expression analysis.
  • Permanently discontinued immunotherapy prior to the first scheduled radiological response assessment.
  • 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).
  • Insufficient clinical documentation to determine the primary outcome (e.g., progression-free survival).

Treatment and study plan

No intervention

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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