Colon CancerNCT04906733
Cetuximab Sensitivity Correlation Between Patient-Derived Organoids and Clinical Response in Colon Cancer Patients.
An observational study of Colon Cancer and Organoids, run by D1 Medical Technology (Shanghai) Co., Ltd, China at 1 site in China.
Trial summary
Eighty patients with RAS/RAF wild-type metastatic right colon cancer will be enrolled and undergo a fresh biopsy of tumor lesion before the standard treatment of chemotherapy. The investigators will establish organoids from the pre-treatment biopsies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colon Cancer, Organoids, Metastatic Cancer
- What is being tested?
- Tumor biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2021to 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The Department of Colorectal Surgery in Fudan University Cancer Hospital is one of the largest colorectal cancer diagnosis and treatment centers in China. In 2019, more than 1,000 cases of recurrent and metastatic colorectal cancer were diagnosed and treated. It is sufficient to obtain samples for this study from patients diagnosed and treated in this department.
Who may be able to join
- Age from 18 to 70 years old, no gender limit
- The primary tumor is located in the right colon, including the ileocecal area, ascending colon, liver flexure, and the right part of the transverse colon.
- Pathologically proved primary intestinal tumor with simultaneous / metachronous metastasis
- Molecular pathology confirmed as RAS/RAF wild type
- Can tolerate and cooperate with the completion of chemotherapy and targeted therapy
- Tissues can be obtained through puncture or colonoscopy for organoid culture
- Complete clinical data, as well as efficacy evaluation data, can be obtained
Who cannot join
- Less than 18 years of age or more than 70 years of age
- The primary tumor is located in the left colon or rectum
- Pathology results can't confirm as colon cancer
- RAS and RAF are mutant confirmed by molecular pathology
- Refuse to cooperate and complete the treatment, or there is a contraindication for chemotherapy or targeted therapy
- No available metastatic lesions tissue
- Unable to obtain complete clinical data or efficacy evaluation data
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Junjie Peng, Dr., +8602164175590, pengjj67@hotmail.com
About this study
Official title: Patient-derived Organoids of RAS/RAF Wild-type Metastatic Right Colon Cancer to Test the Sensitivity and Clinical Consistency of Combined Treatment of Cetuximab.
Eighty patients with RAS/RAF wild-type metastatic right colon cancer will be enrolled and undergo a fresh biopsy of tumor lesion before the standard treatment of chemotherapy. The investigators will establish organoids from the pre-treatment biopsies. Organoids will be exposed to the chemotherapy drugs or chemotherapy drugs combined with cetuximab used for each patient. The sensitivity of chemotherapy drugs or combined cetuximab will be tested in the organoids model. Chemotherapy strategies including 5-fluorouracil only, irinotecan only, oxaliplatin only, FOLFOX, and FOLFIRI. The purpose of this study is to evaluate the consistency and accuracy of a Patient-Derived Organoid (PDO) model of colon cancer to predict the clinical efficacy of combined treatment of cetuximab, which to formulate the best therapy regimen for each given patient.
Read the detailed description
Investigators hypothesize that the cetuximab sensitivity test results on patient-derived organoids can be used to predict the treatment selection of patients with RAS/RAF wild-type metastatic right colon cancer.
Objectives
- To assess the effective rate of cetuximab target therapy on RAS/RAF wild-type right colon cancer
- To assess the consistency of organoid chemotherapy sensitivity and clinical chemotherapy efficacy
- To assess the consistency of organoid cetuximab sensitivity and clinical cetuximab efficacy
The following points will be addressed:
- The biopsy tissue of RAS/RAF wild-type metastatic right colon cancer will be collected and subject to ex vivo 3-D culture to establish patient-derived tumor organoids, which will be used for the drug sensitivity test.
- Enrolled patients will treat with chemotherapy or chemotherapy combined target therapy. The medication regime and treatment cycle will be decided based on the clinical guideline and evidence-based medicine.
- The patient-derived organoid-based drug sensitivity test will compare with clinical treatment data of chemotherapy or chemotherapy combined target therapy, followed by correlation analysis.
- Conditions
- Colon Cancer, Organoids, Metastatic Cancer
- Being tested
- Tumor biopsy
- Medical subject headings
- Colonic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor biopsyProcedure or surgery
Patients with RAS/RAF wild-type metastatic right colon cancer will receive biopsy before the standard treatment of chemotherapy or target therapy.
| Study group | Role | What they receive |
|---|---|---|
| Cancer patient | RAS/RAF wild-type metastatic right colon cancer patients receiving chemotherapy or chemotherapy combined target therapy treatment. Receives: Procedure: Tumor biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of ex vivo sensitivity test on patient-derived organoid models with clinical outcomes
The drug sensitivity tests on patient-derived tumor organoids will compare with the clinical response of the chemo- or targeted therapy treatment. The correlation of organoids sensitivity and patient response will be evaluated.
Measured: 2021.05-2023.05
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start15 Apr 2021
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D1 Medical Technology (Shanghai) Co., Ltd, China
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Responsible party
- Sponsor
- Investigators
- Junjie Peng, Dr., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906733
- Sponsor's protocol ID
- D1med-ZL01
- Status last verified
- Aug 2021
- First submitted
- 27 May 2021
- Last updated
- 13 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-derived Organoids of RAS/RAF Wild-type Metastatic Right Colon Cancer to Test the Sensitivity and Clinical Consistency of Combined Treatment of Cetuximab.
- ClinicalTrials.gov ID
- NCT04906733
- Acronym / sponsor ID
- D1med-ZL01
- Conditions
- Colon Cancer, Organoids, Metastatic Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- D1 Medical Technology (Shanghai) Co., Ltd, ChinaIndustry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 28 May 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.
Eighty patients with RAS/RAF wild-type metastatic right colon cancer will be enrolled and undergo a fresh biopsy of tumor lesion before the standard treatment of chemotherapy. The investigators will establish organoids from the pre-treatment biopsies. Organoids will be exposed to the chemotherapy drugs or chemotherapy drugs combined with cetuximab used for each patient. The sensitivity of chemotherapy drugs or combined cetuximab will be tested in the organoids model. Chemotherapy strategies including 5-fluorouracil only, irinotecan only, oxaliplatin only, FOLFOX, and FOLFIRI. The purpose of this study is to evaluate the consistency and accuracy of a Patient-Derived Organoid (PDO) model of colon cancer to predict the clinical efficacy of combined treatment of cetuximab, which to formulate the best therapy regimen for each given patient.
Detailed description
Investigators hypothesize that the cetuximab sensitivity test results on patient-derived organoids can be used to predict the treatment selection of patients with RAS/RAF wild-type metastatic right colon cancer.
Objectives
- To assess the effective rate of cetuximab target therapy on RAS/RAF wild-type right colon cancer
- To assess the consistency of organoid chemotherapy sensitivity and clinical chemotherapy efficacy
- To assess the consistency of organoid cetuximab sensitivity and clinical cetuximab efficacy
The following points will be addressed:
- The biopsy tissue of RAS/RAF wild-type metastatic right colon cancer will be collected and subject to ex vivo 3-D culture to establish patient-derived tumor organoids, which will be used for the drug sensitivity test.
- Enrolled patients will treat with chemotherapy or chemotherapy combined target therapy. The medication regime and treatment cycle will be decided based on the clinical guideline and evidence-based medicine.
- The patient-derived organoid-based drug sensitivity test will compare with clinical treatment data of chemotherapy or chemotherapy combined target therapy, followed by correlation analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patient | – | Procedure: Tumor biopsyRAS/RAF wild-type metastatic right colon cancer patients receiving chemotherapy or chemotherapy combined target therapy treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Department of Colorectal Surgery in Fudan University Cancer Hospital is one of the largest colorectal cancer diagnosis and treatment centers in China. In 2019, more than 1,000 cases of recurrent and metastatic colorectal cancer were diagnosed and treated. It is sufficient to obtain samples for this study from patients diagnosed and treated in this department.
Key inclusion criteria (7 listed)
- Age from 18 to 70 years old, no gender limit
- The primary tumor is located in the right colon, including the ileocecal area, ascending colon, liver flexure, and the right part of the transverse colon.
- Pathologically proved primary intestinal tumor with simultaneous / metachronous metastasis
- Molecular pathology confirmed as RAS/RAF wild type
- Can tolerate and cooperate with the completion of chemotherapy and targeted therapy
Key exclusion criteria (7 listed)
- Less than 18 years of age or more than 70 years of age
- The primary tumor is located in the left colon or rectum
- Pathology results can't confirm as colon cancer
- RAS and RAF are mutant confirmed by molecular pathology
- Refuse to cooperate and complete the treatment, or there is a contraindication for chemotherapy or targeted therapy
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 |
|---|---|---|
| Tumor biopsyPatients with RAS/RAF wild-type metastatic right colon cancer will receive biopsy before the standard treatment of chemotherapy or target therapy. | Procedure or surgery | Cancer patient |
Primary outcome
Correlation of ex vivo sensitivity test on patient-derived organoid models with clinical outcomes
Time frame: 2021.05-2023.05
The drug sensitivity tests on patient-derived tumor organoids will compare with the clinical response of the chemo- or targeted therapy treatment. The correlation of organoids sensitivity and patient response will be evaluated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Junjie Peng, Dr. principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Organoids, run by D1 Medical Technology (Shanghai) Co., Ltd, China at 1 site 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 7 inclusion and 7 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 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Hanqing Lin, Dr. (+8615921348040, linhq@d1med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of ex vivo sensitivity test on patient-derived organoid models with clinical outcomes (time frame: 2021.05-2023.05). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2021.