Colorectal CancerNCT07919418
A Patient-Derived 3D Bioprinted Colorectal Cancer-Stroma-Immune Triad Model Uncovers Microenvironmental Mechanisms of Chemoresistance and Immune Evasion
An observational study of Colorectal Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Colorectal cancer (CRC) has shifted toward a patient-personalized precision medicine paradigm; however, the high heterogeneity and complex tumor microenvironment (TME) of CRC restrict the development of individualized therapy, and existing preclinical models and multi-omics technologies are insufficient to broadly… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Surgical resection and adjuvant chemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2025to 31 Dec 2028
- How long will I take part?
- 60 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinically and pathologically proven colorectal cancer patients are considered as potential candidates of this study. Medical history will be thouroughly taken by clincal practicitioners. Only patients older than 18 years will be included. Those with medical hostory of other malignancies or serious diseases will be excluded. Patients who are not able to sign the informed consent independently will not be included in this study. All the patients included in this study will receive adjuvant/neoadjuvant chemotherapy and surgical resection for the treatment of CRC.
Who may be able to join
- More than 18 years old
- Diagnosed as colorectal cancer with or without liver metastases before
- Pathologically proven colorectal cancer after surgery
Who cannot join
- Medical history with other malignancies or serious diseases
- Disable to sign the informed consent independently
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
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang
Zhou Bo, 8600-0574-87018701, 1955729746@qq.com
About this study
Official title: Construction of a 3D Multicellular Bioprinted Human Colorectal Cancer Immune-Stromal Microenvironment Model and Its Clinical Translational Research
Colorectal cancer (CRC) has shifted toward a patient-personalized precision medicine paradigm; however, the high heterogeneity and complex tumor microenvironment (TME) of CRC restrict the development of individualized therapy, and existing preclinical models and multi-omics technologies are insufficient to broadly benefit patients. Building on previous research, this project intends to use 3D multicellular bioprinting (3DMP) to incorporate key TME components-cancer-associated fibroblasts (CAFs) and PBMC immune cells-to construct patient-derived CRC-CAFs/PBMC 3DMP models, aiming to apply them to personalized clinical drug screening and prognosis prediction, and to combine them with multi-omics technologies to advance preclinical research on CRC. The implementation of this study will help address the bottleneck of the lack of broadly applicable preclinical models for advancing CRC precision therapy. It has major clinical translational value, will bring significant changes to CRC preclinical research platforms, and will help promote the development of cancer precision medicine.
- Conditions
- Colorectal Cancer
- Being tested
- Surgical resection and adjuvant chemotherapy
- Keywords
- Colorectal Cancer, three-dimensional bioprinting, therapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical resection and adjuvant chemotherapyProcedure or surgery
Surgical resection will be performed for locoregional lesions. Regimens of adjuvant chemotherapy are directed by clinical guidance and experience.
| Study group | Role | What they receive |
|---|---|---|
| Patients with colorectal cancer who underwent surgical resection received adjuvant chemotherapy | Surgical resection will be performed for locoregional lesions. Regimens of adjuvant chemotherapy are directed by clinical guidance and experience. Receives: Procedure: Surgical resection and adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response of 3D tumor models/organoids to the same chemotherapy drugs as the corresponding patients.
The investigators will establish and culture 3D colorectal cancer models and organoids. The 3D models and organoids will be treated with the same chemotherapy drugs as the corresponding patients. The viability of the 3D tumor models and organoids will be observed after treatment and the IC50 of each drug will be calculated. The correlation of 3D model/organoid sensitivity and the patient response will be analyzed.
Measured: 2025.05-2026.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start24 May 2025
- Primary completion1 Nov 2026 (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 Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- 60 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo Medical Center Lihuili Hospital
- Responsible party
- Sponsor
- Investigators
- Yilei Mao, MD PHD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919418
- Sponsor's protocol ID
- CRC-CAFs-3DP-Bioprint
- Status last verified
- Oct 2026
- First submitted
- 1 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) can be accessed with reasonable requests via e-mail. IPD will be shared after the study is completed.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a 3D Multicellular Bioprinted Human Colorectal Cancer Immune-Stromal Microenvironment Model and Its Clinical Translational Research
- ClinicalTrials.gov ID
- NCT07919418
- Acronym / sponsor ID
- CRC-CAFs-3DP-Bioprint
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, three-dimensional bioprinting, therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Ningbo Medical Center Lihuili Hospital
- Study start
- 24 May 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 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.
Colorectal cancer (CRC) has shifted toward a patient-personalized precision medicine paradigm; however, the high heterogeneity and complex tumor microenvironment (TME) of CRC restrict the development of individualized therapy, and existing preclinical models and multi-omics technologies are insufficient to broadly benefit patients. Building on previous research, this project intends to use 3D multicellular bioprinting (3DMP) to incorporate key TME components-cancer-associated fibroblasts (CAFs) and PBMC immune cells-to construct patient-derived CRC-CAFs/PBMC 3DMP models, aiming to apply them to personalized clinical drug screening and prognosis prediction, and to combine them with multi-omics technologies to advance preclinical research on CRC. The implementation of this study will help address the bottleneck of the lack of broadly applicable preclinical models for advancing CRC precision therapy. It has major clinical translational value, will bring significant changes to CRC preclinical research platforms, and will help promote the development of cancer precision medicine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with colorectal cancer who underwent surgical resection received adjuvant chemotherapy | – | Procedure: Surgical resection and adjuvant chemotherapySurgical resection will be performed for locoregional lesions. Regimens of adjuvant chemotherapy are directed by clinical guidance and experience. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinically and pathologically proven colorectal cancer patients are considered as potential candidates of this study. Medical history will be thouroughly taken by clincal practicitioners. Only patients older than 18 years will be included. Those with medical hostory of other malignancies or serious diseases will be excluded. Patients who are not able to sign the informed consent independently will not be included in this study. All the patients included in this study will receive adjuvant/neoadjuvant chemotherapy and surgical resection for the treatment of CRC.
Key inclusion criteria (3 listed)
- More than 18 years old
- Diagnosed as colorectal cancer with or without liver metastases before
- Pathologically proven colorectal cancer after surgery
Key exclusion criteria (2 listed)
- Medical history with other malignancies or serious diseases
- Disable to sign the informed consent independently
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 |
|---|---|---|
| Surgical resection and adjuvant chemotherapySurgical resection will be performed for locoregional lesions. Regimens of adjuvant chemotherapy are directed by clinical guidance and experience. | Procedure or surgery | Patients with colorectal cancer who underwent surgical resection received adjuvant chemotherapy |
Primary outcome
Response of 3D tumor models/organoids to the same chemotherapy drugs as the corresponding patients.
Time frame: 2025.05-2026.12
The investigators will establish and culture 3D colorectal cancer models and organoids. The 3D models and organoids will be treated with the same chemotherapy drugs as the corresponding patients. The viability of the 3D tumor models and organoids will be observed after treatment and the IC50 of each drug will be calculated. The correlation of 3D model/organoid sensitivity and the patient response will be analyzed.
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 5 Nov 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) can be accessed with reasonable requests via e-mail. IPD will be shared after the study is completed.
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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.
Yilei Mao, MD PHD principal investigator
Peking Union Medical College Hospital
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 Colorectal Cancer, run by Peking Union Medical College 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 3 inclusion and 2 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 5 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 Yilei Mao, MD PHD (8600-010-69156042, pumch-liver@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response of 3D tumor models/organoids to the same chemotherapy drugs as the corresponding patients. (time frame: 2025.05-2026.12). 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 5 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.