Cetuximab Sensitivity Correlation Between Patient-Derived Organoids and Clinical Response in Colon Cancer Patients.
Patient-derived Organoids of RAS/RAF Wild-type Metastatic Right Colon Cancer to Test the Sensitivity and Clinical Consistency of Combined Treatment of Cetuximab.
1 other identifier
observational
80
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2021
CompletedFirst Submitted
Initial submission to the registry
May 27, 2021
CompletedFirst Posted
Study publicly available on registry
May 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedAugust 13, 2021
August 1, 2021
2.1 years
May 27, 2021
August 11, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
2021.05-2023.05
Study Arms (1)
Cancer patient
RAS/RAF wild-type metastatic right colon cancer patients receiving chemotherapy or chemotherapy combined target therapy treatment.
Interventions
Patients with RAS/RAF wild-type metastatic right colon cancer will receive biopsy before the standard treatment of chemotherapy or target therapy.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- D1 Medical Technology (Shanghai) Co., Ltd, Chinalead
- Fudan Universitycollaborator
Study Sites (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Biospecimen
Tumor samples of biopsy tissue from enrolled RAS/RAF wild-type metastatic right colon cancer patients are to be collected and subject to organoid isolation followed by the ex vivo drug sensitivity test.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Junjie Peng, Dr.
Fudan University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2021
First Posted
May 28, 2021
Study Start
April 15, 2021
Primary Completion
June 1, 2023
Study Completion
December 1, 2023
Last Updated
August 13, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share