Colo-rectal Cancer
Conditions
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.
Interventions
OTHERNo 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.
Sponsors
West China Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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. |
Countries
China
Outcome results
None listed