Colorectal CancerNCT04755907
3D Bioprinted Models for Predicting Chemotherapy Response in Colorectal Cancer With/Without Liver Metastases
An observational study of Colorectal Cancer and Colorectal Cancer Liver Metastasis, run by Peking Union Medical College Hospital at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colorectal Cancer Liver Metastasis
- What is being tested?
- surgical resection, adjuvant chemotherapy and neoadjuvant therapy
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 4 sitesChina
- Study dates
- 1 Mar 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinically and pathologically proven colorectal cancer patients are considered as potential candidates of this study. Medical history will be thouroughly taken by clincal practicitioners. Only patients older than 18 years will be included. Those with medical hostory of other malignancies or serious diseases will be excluded. Patients who are not able to sign the informed consent independently will not be included in this study. All the patients included in this study will receive adjuvant/neoadjuvant chemotherapy and surgical resection for the treatment of CRC.
Who may be able to join
- More than 18 years old
- Diagnosed as colorectal cancer with or without liver metastases before
- Pathologically proven colorectal cancer after surgery
Who cannot join
- Medical history with other malignancies or serious diseases
- Disable to sign the informed consent independently
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Hong Zhao, MD, 8600-010-87787100, zhaohong@cicams.ac.cn
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Zhiying Yang, MD, 8600-010-84205017, yangzhy@aliyun.com
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100143
Baocai Xing, MD, 8600-010-88196098, xingbaocai88@sina.com
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yilei Mao, MD PhD, 8600-010-69156042, pumch-liver@hotmail.com
Lejia Sun, MD, 8600-18811152352, sunlejia361@163.com
About this study
Official title: 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
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.
- Being tested
- surgical resection, adjuvant chemotherapy, neoadjuvant therapy
- Keywords
- colorectal cancer, colorectal cancer liver metastasis, three-dimensional bioprinting, chemotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical resectionProcedure or surgery
Surgical resection will be performed for locoregional lesions or liver metastases.
adjuvant chemotherapyOther
Regimens of adjuvant chemotherapy are directed by clinical guidance and experience.
neoadjuvant therapyOther
Regimens of neoadjuvant chemotherapy are directed by clinical guidance and experience.
| Study group | Role | What they receive |
|---|---|---|
| Group A | colorectal cancer patients at resectable stage II/III who will receive adjuvant chemotherapy after surgery Receives: Procedure: surgical resection; Other: adjuvant chemotherapy | |
| Group B | colorectal cancer patients at locally advanced stage who will receive neoadjuvant chemotherapy before surgery and adjuvant chemotherapy after surgery Receives: Procedure: surgical resection; Other: adjuvant chemotherapy; Other: neoadjuvant therapy | |
| Group C | colorectal cancer patients with liver metastases Receives: Procedure: surgical resection; Other: adjuvant chemotherapy; Other: neoadjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2021.03-2021.12
Secondary outcomes (1)
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.
Measured: 2021.03-2022.03
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start1 Mar 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, China-Japan Friendship Hospital
- Responsible party
- Sponsor
- Investigators
- Yilei Mao, MD PhD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755907
- Sponsor's protocol ID
- CRC-3D-Bioprint
- Status last verified
- Jul 2022
- First submitted
- 13 Feb 2021
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) can be accessed with reasonable requests via e-mail. IPD will be shared after the study is completed.
Publications
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.
PubMed 30704229Brancato 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.
PubMed 31918229Bruun 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.
PubMed 32299813Yao 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.
PubMed 31761724Xie 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.
PubMed 33007612Sun 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.
PubMed 32582546
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04755907
- Acronym / sponsor ID
- CRC-3D-Bioprint
- Keywords
- colorectal cancer, colorectal cancer liver metastasis, three-dimensional bioprinting, chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, China-Japan Friendship Hospital
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: surgical resection, Other: adjuvant chemotherapycolorectal cancer patients at resectable stage II/III who will receive adjuvant chemotherapy after surgery |
| Group B | – | Procedure: surgical resection, Other: adjuvant chemotherapy, Other: neoadjuvant therapycolorectal cancer patients at locally advanced stage who will receive neoadjuvant chemotherapy before surgery and adjuvant chemotherapy after surgery |
| Group C | – | Procedure: surgical resection, Other: adjuvant chemotherapy, Other: neoadjuvant therapycolorectal cancer patients with liver metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinically and pathologically proven colorectal cancer patients are considered as potential candidates of this study. Medical history will be thouroughly taken by clincal practicitioners. Only patients older than 18 years will be included. Those with medical hostory of other malignancies or serious diseases will be excluded. Patients who are not able to sign the informed consent independently will not be included in this study. All the patients included in this study will receive adjuvant/neoadjuvant chemotherapy and surgical resection for the treatment of CRC.
Key inclusion criteria (3 listed)
- More than 18 years old
- Diagnosed as colorectal cancer with or without liver metastases before
- Pathologically proven colorectal cancer after surgery
Key exclusion criteria (2 listed)
- Medical history with other malignancies or serious diseases
- Disable to sign the informed consent independently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgical resectionSurgical resection will be performed for locoregional lesions or liver metastases. | Procedure or surgery | Group A, Group B, Group C |
| adjuvant chemotherapyRegimens of adjuvant chemotherapy are directed by clinical guidance and experience. | Other | Group A, Group B, Group C |
| neoadjuvant therapyRegimens of neoadjuvant chemotherapy are directed by clinical guidance and experience. | Other | Group B, Group C |
Primary outcome
Response of 3D tumor models/organoids to the same chemotherapy drugs as the corresponding patients.
Time frame: 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.
1 secondary outcome
Response of the colorectal cancer patients to neoadjuvant chemotherapy.
Time frame: 2021.03-2022.03
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Background: PubMed 30704229Wu 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.
- Background: PubMed 31918229Brancato 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.
- Background: PubMed 32299813Bruun 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.
- Background: PubMed 31761724Yao 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.
- Background: PubMed 33007612Xie 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.
- Background: PubMed 32582546Sun 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.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) can be accessed with reasonable requests via e-mail. IPD will be shared after the study is completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yilei Mao, MD PhD principal investigator
Peking Union Medical College Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Colorectal Cancer Liver Metastasis, run by Peking Union Medical College Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yilei Mao, MD PhD (8600-010-69156042, pumch-liver@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response of 3D tumor models/organoids to the same chemotherapy drugs as the corresponding patients. (time frame: 2021.03-2021.12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04755907, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.