Validation of Organoids Potential Use as a Companion Diagnostic in Predicting Neoadjuvant Chemoradiation Sensitivity in Locally Advanced Rectal Cancer
Overview
- Phase
- Not Applicable
- Sponsor
- Zhen Zhang
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Response of the rectal cancer organoids to irradiation and the same chemotherapy drugs as the corresponding patient.
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Time Frame: 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 Outcomes
- Response of the rectal cancer patients to neoadjuvant chemoradiation.(2018.08-2020.11)
Investigators
Zhen Zhang
Professor Zhang
Fudan University