Organoids in Predicting Chemoradiation Sensitivity on Rectal Cancer

Validation of Organoids Potential Use as a Companion Diagnostic in Predicting Neoadjuvant Chemoradiation Sensitivity in Locally Advanced Rectal Cancer

Patients with locally advanced rectal cancer will receive biopsy before the standard treatment of neoadjuvant chemoradiation. The investigators are going to establish organoids model from the pre-treatment biopsies and expose organoids to irradiation and the same chemotherapy drugs. The sensitivity of irradiation and chemotherapy drugs will be tested in the organoids model. Here, the investigators will launch the observational clinical trial to validate whether the organoids could predict the clinical outcome in locally advanced rectal cancer patients underwent neoadjuvant chemoradiation.

Study Overview

• Status: Unknown
• Conditions: Chemoradiation; Rectal Cancer; Organoids
• Intervention / Treatment: Other: Biopsy

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Lijun Shen, MD; Phone Number: 86-2164175590; Email: lijunshen@fudan.edu.cn
• Study Contact Backup: Name: Zhen Zhang, MD; Phone Number: 86-2164175590; Email: zhen_zhang@fudan.edu.cn

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Fudan University
    • Contact: Lijun Shen, MD; Phone Number: 86-2164175590; Email: lijunshen@fudan.edu.cn
    • Contact: Zhen Zhang, MD; Phone Number: 86-2164175590; Email: zhen_zhang@fudan.edu.cn
    • Principal Investigator: Guoqiang Hua, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with locally advanced rectal cancer will receive neoadjuvant chemoradiation. The radiation procedure and concurrent chemotherapy drugs will base on clinical practice.

Description

Inclusion Criteria:

• pathological confirmed adenocarcinoma
• clinical stage T3-4 and/or N+
• the distance from anal verge less than 12 cm
• without distance metastases
• KPS >=70
• without previous anti-cancer therapy
• sign the inform consent

Exclusion Criteria:

• pregnancy or breast-feeding women
• serious medical illness
• baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm; Patients with locally advanced rectal cancer will receive neoadjuvant chemoradiation. The radiation procedure and concurrent chemotherapy drugs will base on clinical practice. Organoids bio-bank of pre-treatment tumor biopsies will be established and exposed to irradiation and the same chemotherapy drugs as the corresponding patient.	Other: Biopsy; Patients with locally advanced rectal cancer will receive biopsy of the primary tumor before neoadjuvant chemoradiation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response of the rectal cancer organoids to irradiation and the same chemotherapy drugs as the corresponding patient.	The investigators will culture rectal cancer organoids and treat with irradiation and the same chemotherapy drugs as the corresponding patient. The number and size of alive organoids will be observed after treatment. The correlation of organoids sensitivity and patient response will be evaluated.	2018.08-2020.11

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response of the rectal cancer patients to neoadjuvant chemoradiation.	The investigators will use pathological tumor regression grade (TRG) to evaluate chemoradiation response of locally advanced rectal cancer patients.	2018.08-2020.11

Collaborators and Investigators

• Sponsor: Zhen Zhang
• Investigators: Principal Investigator: Guoqiang Hua, PhD, Institute of Radiation Medicine, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2018
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: June 20, 2018
• First Submitted That Met QC Criteria: June 23, 2018
• First Posted (Actual): July 5, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2018
• Last Update Submitted That Met QC Criteria: August 17, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: FDRT-R008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No