Colo-rectal CancerNCT07508046
Clinical Study on the Expression of PHGDH and Its Prognostic Value in Colorectal Cancer Patients Receiving Immunotherapy
An observational study of Colo-rectal Cancer, run by West China Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colo-rectal Cancer
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2025to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- No intervention
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PHGDH High | Not described Receives: Other: No intervention | |
| PHGDH Low | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Proportion of participants achieving a complete response (CR) or partial response (PR) per RECIST v1.1 criteria.
Measured: Assessed at 3 months after initiation of immunotherapy.
Secondary outcomes (1)
Progression-Free Survival (PFS)
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.
Measured: Time Frame: From the start of treatment until the first progression event or the end of follow-up (assessed up to 36 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start1 Nov 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuelei Ma MD, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508046
- Sponsor's protocol ID
- Approval No. 149 (2026)
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Expression of PHGDH and Its Prognostic Value in Colorectal Cancer Patients Receiving Immunotherapy
- ClinicalTrials.gov ID
- NCT07508046
- Acronym / sponsor ID
- Approval No. 149 (2026)
- Conditions
- Colo-rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PHGDH High | – | Other: No intervention |
| PHGDH Low | – | Other: No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo 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. | Other | PHGDH High, PHGDH Low |
Primary outcome
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.
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colo-rectal Cancer, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Assessed at 3 months after initiation of immunotherapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.