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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colorectal Cancer, Colorectal Cancer Liver Metastasis

Intervention / Treatment
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* Procedure: surgical resection
* Other: adjuvant chemotherapy
* Other: neoadjuvant therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>colorectal cancer patients at resectable stage II/III who will receive adjuvant chemotherapy after surgery | Procedure: surgical resection<br>* Surgical resection will be performed for locoregional lesions or liver metastases.<br>Other: adjuvant chemotherapy<br>* Regimens of adjuvant chemotherapy are directed by clinical guidance and experience.<br>|
| Group B<br>colorectal cancer patients at locally advanced stage who will receive neoadjuvant chemotherapy before surgery and adjuvant chemotherapy after surgery | Procedure: surgical resection<br>* Surgical resection will be performed for locoregional lesions or liver metastases.<br>Other: adjuvant chemotherapy<br>* Regimens of adjuvant chemotherapy are directed by clinical guidance and experience.<br>Other: neoadjuvant therapy<br>* Regimens of neoadjuvant chemotherapy are directed by clinical guidance and experience.<br>|
| Group C<br>colorectal cancer patients with liver metastases | Procedure: surgical resection<br>* Surgical resection will be performed for locoregional lesions or liver metastases.<br>Other: adjuvant chemotherapy<br>* Regimens of adjuvant chemotherapy are directed by clinical guidance and experience.<br>Other: neoadjuvant therapy<br>* Regimens of neoadjuvant chemotherapy are directed by clinical guidance and experience.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2021.03-2021.12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response of the colorectal cancer patients to neoadjuvant chemotherapy. | For patients who receive neoadjuvant chemotherapy before surgery, the response to neoadjuvant chemotherapy will be evaluated according to clinical imaging results and the RECIST scores. | 2021.03-2022.03 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, colorectal cancer liver metastasis, three-dimensional bioprinting, chemotherapy