Cetuximab Sensitivity Correlation Between Patient-Derived Organoids and Clinical Response in Colon Cancer Patients.

August 11, 2021 updated by: D1 Medical Technology (Shanghai) Co., Ltd, China

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

  1. To assess the effective rate of cetuximab target therapy on RAS/RAF wild-type right colon cancer
  2. To assess the consistency of organoid chemotherapy sensitivity and clinical chemotherapy efficacy
  3. To assess the consistency of organoid cetuximab sensitivity and clinical cetuximab efficacy

The following points will be addressed:

  1. 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.
  2. 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.
  3. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Hanqing Lin, Dr.
  • Phone Number: +8615921348040
  • Email: linhq@d1med.com

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  1. Age from 18 to 70 years old, no gender limit
  2. 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.
  3. Pathologically proved primary intestinal tumor with simultaneous / metachronous metastasis
  4. Molecular pathology confirmed as RAS/RAF wild type
  5. Can tolerate and cooperate with the completion of chemotherapy and targeted therapy
  6. Tissues can be obtained through puncture or colonoscopy for organoid culture
  7. Complete clinical data, as well as efficacy evaluation data, can be obtained

Exclusion Criteria:

  1. Less than 18 years of age or more than 70 years of age
  2. The primary tumor is located in the left colon or rectum
  3. Pathology results can't confirm as colon cancer
  4. RAS and RAF are mutant confirmed by molecular pathology
  5. Refuse to cooperate and complete the treatment, or there is a contraindication for chemotherapy or targeted therapy
  6. No available metastatic lesions tissue
  7. Unable to obtain complete clinical data or efficacy evaluation data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cancer patient
RAS/RAF wild-type metastatic right colon cancer patients receiving chemotherapy or chemotherapy combined target therapy treatment.
Procedure: Tumor biopsy
Patients with RAS/RAF wild-type metastatic right colon cancer will receive biopsy before the standard treatment of chemotherapy or target therapy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2021.05-2023.05

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
D1 Medical Technology (Shanghai) Co., Ltd, China

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fudan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Junjie Peng, Dr., Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D1med-ZL01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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