To explore the value of PTC drug screening technique in selecting neoadjuvant therapy for advanced gastrointestinal cancer.
In this study, patients diagnosed with advanced gastrointestinal cancer including locally advanced gastric cancer, locally advanced colorectal cancer and colorectal cancer with liver metastasis. Tumor sample will be collected by endoscopy biopsy, needle biopsy or surgery, which will used for PTC drug screening. Patients will be randomized to two groups. Patients in experiment group will receive neoadjuvant therapy based on PTC drug screening, and patients in control group will receive neoadjuvant therapy based on clinical experience. 2-4 cycles of neoadjuvant therapy will be administered. Patients appropriate for surgery will receive radical surgery after neoadjuvant therapy. Pathological response will be compared primarily between these two groups. This is a randomized controlled, open-label and sequential designed clinical trial. All neoadjuvant therapy used in this study or for PTC drug screening comply with NCCN (National comprehensive cancer network) or CSCO (Chinese Society of Clinical Oncology) guidelines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
420
PTC is an in vitro tumor model, which serves as a structural and functional unit recapitulating the original tumors in genotype, phenotype, and drug response. PTC will be used in drug screening.
pathological complete response rate(pCR)
having no invasive cancer left in the resected sample
Time frame: immediately evaluated after surgery
pathological response rate
tumor regression grade 0-2
Time frame: immediately evaluated after surgery
objective response rate(ORR)
CR+PR according to RECIST 1.1
Time frame: evaluated by imaging before surgery
disease control rate(DCR)
CR+PR+SD according to RECIST 1.1
Time frame: evaluated by imaging before surgery
R0 resection rate
microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed
Time frame: immediately evaluated after surgery
prediction accuracy of PTC
consistency between the effect of neoadjuvant chemotherapy and the result of PTC assay
Time frame: immediately evaluated after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.