Clinical trial · Observational
Clinical Study on the Expression of PHGDH and Its Prognostic Value in Colorectal Cancer Patients Receiving Immunotherapy
NCT07508046CI-TRIAL-00107169completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colo-rectal Cancer | Colon Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- PHGDH High
- interventionNames
- Other: No intervention
- label
- PHGDH Low
- interventionNames
- Other: No intervention
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Assessed at 3 months after initiation of immunotherapy.
- description
- Proportion of participants achieving a complete response (CR) or partial response (PR) per RECIST v1.1 criteria.
Secondary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.