Chemoradiation, Organoids, Rectal Cancer
Conditions
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.
Interventions
OTHERBiopsy
Patients with locally advanced rectal cancer will receive biopsy of the primary tumor before neoadjuvant chemoradiation.
Sponsors
Zhen Zhang
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactLijun Shen, MD
Backup ContactZhen Zhang, MD
Outcome results
None listed