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

NCT07508046 | Completed

• 1 other identifier: Approval No. 149 (2026)
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colo-rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  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 Outcomes (1)

• Progression-Free Survival (PFS)

  Time Frame: From the start of treatment until the first progression event or the end of follow-up (assessed up to 36 months).

Study Arms (2)

PHGDH High

Other: No intervention

PHGDH Low

Other: No intervention

Interventions

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.

PHGDH High; PHGDH Low

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: November 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

CN (1)