Status:

UNKNOWN

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

Lead Sponsor:

D1 Medical Technology (Shanghai) Co., Ltd, China

Collaborating Sponsors:

Fudan University

Conditions:

Colon Cancer

Organoids

Eligibility:

All Genders

18-70 years

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 e...

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 co...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

April 15 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2023

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT04906733

Start Date

April 15 2021

End Date

December 1 2023

Last Update

August 13 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032