Organoids in Predicting Chemoradiation Sensitivity on Rectal Cancer

• Conditions: Chemoradiation; Organoids; Rectal Cancer
• Interventions: Other: Biopsy

• Registration Number: NCT03577808
• Lead Sponsor: Zhen Zhang

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-20
• Study First Submitted QC: 2018-06-23
• Study First Posted: 2018-07-05
• Status Verified: 2018-08
• Study Start: 2018-08-17
• Last Update Submitted: 2018-08-17
• Last Update Posted: 2018-08-20
• Primary Completion: 2020-08-01
• Study Completion: 2020-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm	Biopsy	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.

Primary Outcome Measures

Name	Time	Method
Response of the rectal cancer organoids to irradiation and the same chemotherapy drugs as the corresponding patient.	2018.08-2020.11	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fudan University; 🇨🇳 Shanghai, China