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3D Bioprinted Models for Predicting Chemotherapy Response in Colorectal Cancer With/Without Liver Metastases

Validation of the Three-dimensional Bioprinted Tumor Models as a Predictive Method of the Response to Chemotherapy for Colorectal Cancer With or Without Liver Metastases

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04755907
Enrollment
120
Registered
2021-02-16
Start date
2021-03-01
Completion date
2023-12-31
Last updated
2022-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Colorectal Cancer Liver Metastasis

Keywords

colorectal cancer, colorectal cancer liver metastasis, three-dimensional bioprinting, chemotherapy

Brief summary

The therapeutic regimens of adjuvant and neoadjuvant chemotherapy for colorectal cancer (CRC) remain largely relied on clinical experience, and thus preclinical models are needed to guide individualized medicine. The investigators are going to establish 3D bioprinted CRC models and organoids from surgically resected tumor tissues of CRC patients with or without liver metastases. In vitro 3D models and organoids will be treated with the same chemotherapy drugs with the corresponding patients from whom the models are derived. The sensitivity of chemotherapy drugs will be tested in these two types of in vitro models, and the actual response to chemotherapy in patients will be evaluated. The predictive ability of 3D models for chemotherapy sensitivity in CRC patients will be compared with that of the organoids. This observational study will validate the potential value of 3D bioprinted tumor models in predicting the response to chemotherapy in CRC.

Interventions

PROCEDUREsurgical resection

Surgical resection will be performed for locoregional lesions or liver metastases.

OTHERadjuvant chemotherapy

Regimens of adjuvant chemotherapy are directed by clinical guidance and experience.

OTHERneoadjuvant therapy

Regimens of neoadjuvant chemotherapy are directed by clinical guidance and experience.

Sponsors

Peking University Cancer Hospital & Institute
CollaboratorOTHER
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
CollaboratorOTHER
China-Japan Friendship Hospital
CollaboratorOTHER
Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* More than 18 years old * Diagnosed as colorectal cancer with or without liver metastases before * Pathologically proven colorectal cancer after surgery

Exclusion criteria

* Medical history with other malignancies or serious diseases * Disable to sign the informed consent independently

Design outcomes

Primary

MeasureTime frameDescription
Response of 3D tumor models/organoids to the same chemotherapy drugs as the corresponding patients.2021.03-2021.12The 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.

Secondary

MeasureTime frameDescription
Response of the colorectal cancer patients to neoadjuvant chemotherapy.2021.03-2022.03For patients who receive neoadjuvant chemotherapy before surgery, the response to neoadjuvant chemotherapy will be evaluated according to clinical imaging results and the RECIST scores.

Other

MeasureTime frameDescription
Response of the colorectal cancer patients to adjuvant chemotherapy.2021.03-2023.12The response to adjuvant chemotherapy will be evaluated according to disease free survival (DFS). Regular follow-ups will be conducted, and DFS is difined as the interval between the date of surgery and the date of last follow-up or recurrence/progression.

Countries

China

Contacts

Primary ContactYilei Mao, MD PhD
pumch-liver@hotmail.com8600-010-69156042
Backup ContactLejia Sun, MD
sunlejia361@163.com8600-18811152352

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026