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

• Conditions: Colorectal Cancer; Colorectal Cancer Liver Metastasis
• Interventions: Procedure: surgical resection; Other: adjuvant chemotherapy; Other: neoadjuvant therapy

• Registration Number: NCT04755907
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-13
• Study First Submitted QC: 2021-02-13
• Study First Posted: 2021-02-16
• Study Start: 2021-03-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-16
• Last Update Posted: 2022-07-19
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	surgical resection	colorectal cancer patients at resectable stage II/III who will receive adjuvant chemotherapy after surgery
Group C	surgical resection	colorectal cancer patients with liver metastases
Group C	adjuvant chemotherapy	colorectal cancer patients with liver metastases
Group C	neoadjuvant therapy	colorectal cancer patients with liver metastases
Group B	adjuvant chemotherapy	colorectal cancer patients at locally advanced stage who will receive neoadjuvant chemotherapy before surgery and adjuvant chemotherapy after surgery
Group B	neoadjuvant therapy	colorectal cancer patients at locally advanced stage who will receive neoadjuvant chemotherapy before surgery and adjuvant chemotherapy after surgery
Group A	adjuvant chemotherapy	colorectal cancer patients at resectable stage II/III who will receive adjuvant chemotherapy after surgery
Group B	surgical resection	colorectal cancer patients at locally advanced stage who will receive neoadjuvant chemotherapy before surgery and adjuvant chemotherapy after surgery

Primary Outcome Measures

Name	Time	Method
Response of 3D tumor models/organoids to the same chemotherapy drugs as the corresponding patients.	2021.03-2021.12	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.

Secondary Outcome Measures

Name	Time	Method
Response of the colorectal cancer patients to neoadjuvant chemotherapy.	2021.03-2022.03	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.

Trial Locations

Locations (4)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China