Organoids in Predicting Chemoradiation Sensitivity on Rectal Cancer

Zhen Zhang80 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Organoids Rectal Cancer Chemoradiation

Interventions

BiopsyOTHER

Patients with locally advanced rectal cancer will receive biopsy of the primary tumor before neoadjuvant chemoradiation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 2018.08-2020.11

Secondary Outcomes

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.