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

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Enrolling

Conditions

Colorectal Cancer Liver Metastasis
Colorectal Cancer

Treatments

Other: neoadjuvant therapy
Procedure: surgical resection
Other: adjuvant chemotherapy

Study type

Observational

Funder types

Other

Identifiers

NCT04755907
CRC-3D-Bioprint

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

120 participants in 3 patient groups

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

Trial contacts and locations

4

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Central trial contact

Yilei Mao, MD PhD; Lejia Sun, MD

Data sourced from clinicaltrials.gov

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