Organoids in Predicting Chemoradiation Sensitivity on Rectal Cancer

Zhen Zhang

Status: Unknown

Conditions: Chemoradiation; Organoids; Rectal Cancer

Treatments: Other: Biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT03577808

FDRT-R008

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 1 patient group

Arm

Description:

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.

Treatment:

Other: Biopsy