Rectal NeoplasmsNCT07920770
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
An observational study of Rectal Neoplasms, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
This prospective observational study characterises the tumour immune microenvironment and microbial ecology of locally advanced rectal cancer before and during neoadjuvant therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Neoplasms
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with locally advanced rectal adenocarcinoma treated at Fujian Medical University Union Hospital, China, from whom tumour tissue and peripheral blood were collected before and during neoadjuvant therapy.
Who may be able to join
- Age 18 to 75 years
- Eastern Cooperative Oncology Group performance status 0-1
- Histologically confirmed rectal adenocarcinoma
- Locally advanced disease staged as cT3-T4N0 or cT2-T4N+ without distant metastasis (AJCC 8th edition)
- Lower border of the tumour within 10 cm of the anal verge
- Scheduled to receive neoadjuvant therapy followed by surgery, with tumour tissue and peripheral blood available before and during neoadjuvant therapy
- Written informed consent for fresh biopsy or surgical tissue, or a waiver granted by the institutional ethics committee for archival specimens
Who cannot join
- Insufficient tissue or nucleic acid quality for the planned profiling assays
- Incomplete clinical records precluding assessment of pathological or clinical response
- A history of other malignancy within 5 years other than adequately treated carcinoma in situ or basal cell carcinoma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
About this study
Official title: A Prospective Observational Study of Tumour Microenvironment Remodelling During Neoadjuvant Therapy in Locally Advanced Rectal Cancer Using Single-Cell and Spatial Multi-omics
This prospective observational study characterises the tumour immune microenvironment and microbial ecology of locally advanced rectal cancer before and during neoadjuvant therapy. Tumour tissue and peripheral blood are profiled by whole-genome sequencing, single-cell RNA sequencing with paired T-cell and B-cell receptor repertoire sequencing, spatial transcriptomics of formalin-fixed paraffin-embedded sections, multiplex immunofluorescence, and blood-based proteomic, cytokine and bulk T-cell receptor analyses. The study examines how immune and stromal states change during treatment and how they relate to major pathological response.
Read the detailed description
Locally advanced rectal cancer is increasingly treated with total neoadjuvant therapy combining short-course radiotherapy, chemotherapy and programmed cell death protein 1 (PD-1) blockade, but the effect of treatment sequence on the tumour microenvironment is unresolved, and few patients have been profiled with matched pre- and on-treatment single-cell data. In this observational study, we collect tumour tissue and peripheral blood from patients with locally advanced rectal cancer at baseline, before any neoadjuvant treatment, and again after completion of short-course hypofractionated radiotherapy (5 Gy in 5 fractions) followed by one cycle of chemo-immunotherapy, together with archival formalin-fixed paraffin-embedded tissue where available. Additional formalin-fixed paraffin-embedded specimens from treatment-naive patients undergoing primary surgery, and from end-of-treatment biopsies, are used as controls for the spatial analyses. Fresh tumour tissue is analysed by whole-genome sequencing and by single-cell RNA sequencing with paired T-cell and B-cell receptor repertoire sequencing. Formalin-fixed paraffin-embedded tissue is analysed by spatial transcriptomics and multiplex immunofluorescence. Peripheral blood mononuclear cells are analysed by bulk T-cell receptor repertoire sequencing, and plasma or serum by proteomic and cytokine profiling where material permits. The principal clinical endpoint is major pathological response (mPR) at resection. We examine changes in immune and stromal populations between baseline and the on-treatment time point, features of the immune microenvironment associated with mPR, and, as exploratory analyses, the tumour microbial ecology associated with response together with differences between neoadjuvant treatment sequences. Analyses are descriptive and hypothesis-generating; no intervention, treatment assignment or change in clinical care is involved. The study was approved by the Ethics Committee of Fujian Medical University Union Hospital (2024KY297, approved 30 December 2024; and 2024KJCX060, approved 18 September 2024); archival specimens are used under a waiver of additional informed consent, and fresh biopsy or surgical tissue and blood are collected with written informed consent.
- Conditions
- Rectal Neoplasms
- Keywords
- rectal cancer, neoadjuvant therapy, single-cell RNA sequencing, spatial transcriptomics, tumour immune microenvironment, pathological complete response
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Achieved pathological or clinical complete response | Patients whose resection specimen showed a pathological complete response (ypT0N0) or who achieved a sustained clinical complete response, from whom pre-treatment and on-treatment tissue and blood were profiled. | |
| Did not achieve pathological or clinical complete response | Patients with residual viable tumour at resection or without a sustained clinical complete response, from whom pre-treatment and on-treatment tissue and blood were profiled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in immune and stromal cell composition in tumour tissue during neoadjuvant therapy
Cell-type composition and transcriptional states of T, natural killer (NK), B and myeloid populations and of stromal subsets before treatment and during neoadjuvant therapy, determined by single-cell RNA sequencing.
Measured: Baseline (before treatment) and week 4 after treatment initiation
Major pathological response (mPR) and its association with immune microenvironment features
Proportion of patients achieving major pathological response, defined as 10% or less residual viable tumour at resection, and the association of pre-treatment and on-treatment immune microenvironment features with mPR.
Measured: Through study completion, an average of 4 years
Secondary outcomes (7)
Transcriptional states of immune populations before and during treatment
Exhaustion, activation and memory programmes of T and NK cells and B-cell states, determined by single-cell RNA sequencing with paired T-cell and B-cell receptor repertoire sequencing.
Measured: Baseline (before treatment) and week 4 after treatment initiation
Spatial organisation of tumour and immune compartments before and during treatment
Spatial distribution of tumour, immune and stromal compartments determined by spatial transcriptomics of formalin-fixed paraffin-embedded sections and multiplex immunofluorescence, compared with specimens from treatment-naive patients undergoing primary surgery and from end-of-treatment biopsies as controls.
Measured: Baseline (before treatment) and week 4 after treatment initiation
Comparison of microenvironment remodelling between neoadjuvant treatment sequences
Between-group comparison of the change in tumour microenvironment composition between baseline and week 4, expressed as the percentage of cluster of differentiation 8 (CD8)-positive T cells, NK cells, B cells and plasma cells among all cells measured by single-cell RNA sequencing, in patients receiving radiotherapy before versus after chemo-immunotherapy.
Measured: Through study completion, an average of 4 years
Somatic genomic alterations associated with response to neoadjuvant therapy
Somatic mutations, copy-number alterations and mutational signatures determined by whole-genome sequencing of tumour tissue before and during neoadjuvant therapy.
Measured: Baseline (before treatment) and week 4 after treatment initiation
Clonal diversity of the peripheral blood T-cell receptor repertoire
Diversity and distribution of T-cell receptor clonotypes in peripheral blood mononuclear cells, expressed as the Shannon diversity index and the proportion of expanded clonotypes, measured by bulk T-cell receptor repertoire sequencing.
Measured: Baseline (before treatment) and week 4 after treatment initiation
Correlation of tumour microbial composition with major pathological response
Correlation between the relative abundance of tumour-associated bacterial taxa, expressed as the percentage of sequencing reads assigned to each taxon measured by small-subunit ribosomal RNA gene sequencing or shotgun metagenomic sequencing of tumour tissue, and major pathological response, expressed as the percentage of patients with 10% or less residual viable tumour at resection (exploratory).
Measured: Baseline (before treatment) and week 4 after treatment initiation
Plasma protein and cytokine concentrations before and during neoadjuvant therapy
Concentrations of plasma or serum proteins and cytokines, expressed in pg/mL, measured by multiplex proteomic and cytokine assays.
Measured: Baseline (before treatment) and week 4 after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Jan 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong Yang, Fujian Medical University Union Hospital
- Investigators
- Jian Liu (jianliu@nankai.edu.cn), PhD, Study director, Nankai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920770
- Sponsor's protocol ID
- FJMUUH-RECT-OMICS-2024-01
- Status last verified
- Nov 2026
- First submitted
- 27 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data, including clinical records and sample-level identifiers, will not be shared. De-identified single-cell, bulk RNA sequencing and spatial transcriptomic data will be deposited in the Genome Sequence Archive for Human (GSA-Human), National Genomics Data Center, China, and will be made available for research use through the repository according to its access policy after publication.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Tumour Microenvironment Remodelling During Neoadjuvant Therapy in Locally Advanced Rectal Cancer Using Single-Cell and Spatial Multi-omics
- ClinicalTrials.gov ID
- NCT07920770
- Acronym / sponsor ID
- FJMUUH-RECT-OMICS-2024-01
- Conditions
- Rectal Neoplasms
- Keywords
- rectal cancer, neoadjuvant therapy, single-cell RNA sequencing, spatial transcriptomics, tumour immune microenvironment, pathological complete response
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Nov 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 prospective observational study characterises the tumour immune microenvironment and microbial ecology of locally advanced rectal cancer before and during neoadjuvant therapy. Tumour tissue and peripheral blood are profiled by whole-genome sequencing, single-cell RNA sequencing with paired T-cell and B-cell receptor repertoire sequencing, spatial transcriptomics of formalin-fixed paraffin-embedded sections, multiplex immunofluorescence, and blood-based proteomic, cytokine and bulk T-cell receptor analyses. The study examines how immune and stromal states change during treatment and how they relate to major pathological response.
Detailed description
Locally advanced rectal cancer is increasingly treated with total neoadjuvant therapy combining short-course radiotherapy, chemotherapy and programmed cell death protein 1 (PD-1) blockade, but the effect of treatment sequence on the tumour microenvironment is unresolved, and few patients have been profiled with matched pre- and on-treatment single-cell data. In this observational study, we collect tumour tissue and peripheral blood from patients with locally advanced rectal cancer at baseline, before any neoadjuvant treatment, and again after completion of short-course hypofractionated radiotherapy (5 Gy in 5 fractions) followed by one cycle of chemo-immunotherapy, together with archival formalin-fixed paraffin-embedded tissue where available. Additional formalin-fixed paraffin-embedded specimens from treatment-naive patients undergoing primary surgery, and from end-of-treatment biopsies, are used as controls for the spatial analyses. Fresh tumour tissue is analysed by whole-genome sequencing and by single-cell RNA sequencing with paired T-cell and B-cell receptor repertoire sequencing. Formalin-fixed paraffin-embedded tissue is analysed by spatial transcriptomics and multiplex immunofluorescence. Peripheral blood mononuclear cells are analysed by bulk T-cell receptor repertoire sequencing, and plasma or serum by proteomic and cytokine profiling where material permits. The principal clinical endpoint is major pathological response (mPR) at resection. We examine changes in immune and stromal populations between baseline and the on-treatment time point, features of the immune microenvironment associated with mPR, and, as exploratory analyses, the tumour microbial ecology associated with response together with differences between neoadjuvant treatment sequences. Analyses are descriptive and hypothesis-generating; no intervention, treatment assignment or change in clinical care is involved. The study was approved by the Ethics Committee of Fujian Medical University Union Hospital (2024KY297, approved 30 December 2024; and 2024KJCX060, approved 18 September 2024); archival specimens are used under a waiver of additional informed consent, and fresh biopsy or surgical tissue and blood are collected with written informed consent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Achieved pathological or clinical complete response | – | –Patients whose resection specimen showed a pathological complete response (ypT0N0) or who achieved a sustained clinical complete response, from whom pre-treatment and on-treatment tissue and blood were profiled. |
| Did not achieve pathological or clinical complete response | – | –Patients with residual viable tumour at resection or without a sustained clinical complete response, from whom pre-treatment and on-treatment tissue and blood were profiled. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with locally advanced rectal adenocarcinoma treated at Fujian Medical University Union Hospital, China, from whom tumour tissue and peripheral blood were collected before and during neoadjuvant therapy.
Key inclusion criteria (7 listed)
- Age 18 to 75 years
- Eastern Cooperative Oncology Group performance status 0-1
- Histologically confirmed rectal adenocarcinoma
- Locally advanced disease staged as cT3-T4N0 or cT2-T4N+ without distant metastasis (AJCC 8th edition)
- Lower border of the tumour within 10 cm of the anal verge
Key exclusion criteria (3 listed)
- Insufficient tissue or nucleic acid quality for the planned profiling assays
- Incomplete clinical records precluding assessment of pathological or clinical response
- A history of other malignancy within 5 years other than adequately treated carcinoma in situ or basal cell carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in immune and stromal cell composition in tumour tissue during neoadjuvant therapy
Time frame: Baseline (before treatment) and week 4 after treatment initiation
Cell-type composition and transcriptional states of T, natural killer (NK), B and myeloid populations and of stromal subsets before treatment and during neoadjuvant therapy, determined by single-cell RNA sequencing.
Major pathological response (mPR) and its association with immune microenvironment features
Time frame: Through study completion, an average of 4 years
Proportion of patients achieving major pathological response, defined as 10% or less residual viable tumour at resection, and the association of pre-treatment and on-treatment immune microenvironment features with mPR.
7 secondary outcomes
Transcriptional states of immune populations before and during treatment
Time frame: Baseline (before treatment) and week 4 after treatment initiation
Spatial organisation of tumour and immune compartments before and during treatment
Time frame: Baseline (before treatment) and week 4 after treatment initiation
Comparison of microenvironment remodelling between neoadjuvant treatment sequences
Time frame: Through study completion, an average of 4 years
Somatic genomic alterations associated with response to neoadjuvant therapy
Time frame: Baseline (before treatment) and week 4 after treatment initiation
Clonal diversity of the peripheral blood T-cell receptor repertoire
Time frame: Baseline (before treatment) and week 4 after treatment initiation
Correlation of tumour microbial composition with major pathological response
Time frame: Baseline (before treatment) and week 4 after treatment initiation
Plasma protein and cytokine concentrations before and during neoadjuvant therapy
Time frame: Baseline (before treatment) and week 4 after treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data, including clinical records and sample-level identifiers, will not be shared. De-identified single-cell, bulk RNA sequencing and spatial transcriptomic data will be deposited in the Genome Sequence Archive for Human (GSA-Human), National Genomics Data Center, China, and will be made available for research use through the repository according to its access policy after publication.
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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.
Jian Liu (jianliu@nankai.edu.cn), PhD study director
Nankai University
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 Rectal Neoplasms, run by Fujian Medical University Union 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 7 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 6 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wan-cai Que (0086-0591-86218304, xhyyjgb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in immune and stromal cell composition in tumour tissue during neoadjuvant therapy (time frame: Baseline (before treatment) and week 4 after treatment initiation). The study lists 2 primary outcomes in all. 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 6 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.