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

NCT ID: NCT04755907

Last Updated: 2022-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-12-31

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.

Detailed Description

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Conditions

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Colorectal Cancer Colorectal Cancer Liver Metastasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

colorectal cancer patients at resectable stage II/III who will receive adjuvant chemotherapy after surgery

surgical resection

Intervention Type PROCEDURE

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

adjuvant chemotherapy

Intervention Type OTHER

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

Group B

colorectal cancer patients at locally advanced stage who will receive neoadjuvant chemotherapy before surgery and adjuvant chemotherapy after surgery

surgical resection

Intervention Type PROCEDURE

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

adjuvant chemotherapy

Intervention Type OTHER

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

neoadjuvant therapy

Intervention Type OTHER

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

Group C

colorectal cancer patients with liver metastases

surgical resection

Intervention Type PROCEDURE

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

adjuvant chemotherapy

Intervention Type OTHER

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

neoadjuvant therapy

Intervention Type OTHER

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

Interventions

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surgical resection

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

Intervention Type PROCEDURE

adjuvant chemotherapy

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

Intervention Type OTHER

neoadjuvant therapy

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Cancer Hospital & Institute

OTHER

Sponsor Role collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role collaborator

China-Japan Friendship Hospital

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yilei Mao, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yilei Mao, MD PhD

Role: CONTACT

8600-010-69156042

Lejia Sun, MD

Role: CONTACT

8600-18811152352

Facility Contacts

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Hong Zhao, MD

Role: primary

8600-010-87787100

Zhiying Yang, MD

Role: primary

8600-010-84205017

Baocai Xing, MD

Role: primary

8600-010-88196098

Yilei Mao, MD PhD

Role: primary

8600-010-69156042

Lejia Sun, MD

Role: backup

8600-18811152352

References

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Wu J, Lu AD, Zhang LP, Zuo YX, Jia YP. [Study of clinical outcome and prognosis in pediatric core binding factor-acute myeloid leukemia]. Zhonghua Xue Ye Xue Za Zhi. 2019 Jan 14;40(1):52-57. doi: 10.3760/cma.j.issn.0253-2727.2019.01.010. Chinese.

Reference Type BACKGROUND
PMID: 30704229 (View on PubMed)

Brancato V, Oliveira JM, Correlo VM, Reis RL, Kundu SC. Could 3D models of cancer enhance drug screening? Biomaterials. 2020 Feb;232:119744. doi: 10.1016/j.biomaterials.2019.119744. Epub 2019 Dec 26.

Reference Type BACKGROUND
PMID: 31918229 (View on PubMed)

Bruun J, Kryeziu K, Eide PW, Moosavi SH, Eilertsen IA, Langerud J, Rosok B, Totland MZ, Brunsell TH, Pellinen T, Saarela J, Bergsland CH, Palmer HG, Brudvik KW, Guren T, Dienstmann R, Guren MG, Nesbakken A, Bjornbeth BA, Sveen A, Lothe RA. Patient-Derived Organoids from Multiple Colorectal Cancer Liver Metastases Reveal Moderate Intra-patient Pharmacotranscriptomic Heterogeneity. Clin Cancer Res. 2020 Aug 1;26(15):4107-4119. doi: 10.1158/1078-0432.CCR-19-3637. Epub 2020 Apr 16.

Reference Type BACKGROUND
PMID: 32299813 (View on PubMed)

Yao Y, Xu X, Yang L, Zhu J, Wan J, Shen L, Xia F, Fu G, Deng Y, Pan M, Guo Q, Gao X, Li Y, Rao X, Zhou Y, Liang L, Wang Y, Zhang J, Zhang H, Li G, Zhang L, Peng J, Cai S, Hu C, Gao J, Clevers H, Zhang Z, Hua G. Patient-Derived Organoids Predict Chemoradiation Responses of Locally Advanced Rectal Cancer. Cell Stem Cell. 2020 Jan 2;26(1):17-26.e6. doi: 10.1016/j.stem.2019.10.010. Epub 2019 Nov 21.

Reference Type BACKGROUND
PMID: 31761724 (View on PubMed)

Xie F, Sun L, Pang Y, Xu G, Jin B, Xu H, Lu X, Xu Y, Du S, Wang Y, Feng S, Sang X, Zhong S, Wang X, Sun W, Zhao H, Zhang H, Yang H, Huang P, Mao Y. Three-dimensional bio-printing of primary human hepatocellular carcinoma for personalized medicine. Biomaterials. 2021 Jan;265:120416. doi: 10.1016/j.biomaterials.2020.120416. Epub 2020 Sep 22.

Reference Type BACKGROUND
PMID: 33007612 (View on PubMed)

Sun L, Yang H, Wang Y, Zhang X, Jin B, Xie F, Jin Y, Pang Y, Zhao H, Lu X, Sang X, Zhang H, Lin F, Sun W, Huang P, Mao Y. Application of a 3D Bioprinted Hepatocellular Carcinoma Cell Model in Antitumor Drug Research. Front Oncol. 2020 Jun 3;10:878. doi: 10.3389/fonc.2020.00878. eCollection 2020.

Reference Type BACKGROUND
PMID: 32582546 (View on PubMed)

Other Identifiers

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CRC-3D-Bioprint

Identifier Type: -

Identifier Source: org_study_id

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