Gastrointestinal Neoplasms
Conditions
Keywords
neoadjuvant, chemotherapy
Brief summary
To explore the value of PTC drug screening technique in selecting neoadjuvant therapy for advanced gastrointestinal cancer.
Detailed description
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.
Interventions
OTHERPTC drug screening
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.
Sponsors
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* diagnosed of gastrointestinal adenocarcinoma by biopsy * existence of initially resectable lesions evaluated by investigators * indications of neoadjuvant chemotherapy including: 1) locally advanced gastric cancer cT1-2N1-3M0 & cT3-4N0-3M0; 2) locally advanced colorectal cancer cT3-4 or N+; 3)colorectal carcinoma with synchronous liver metastases: CRS≤2; 4)other patients who are considered to be appropriate to receive neoadjuvant chemotherapy determined by MDT * never receive any tumor related treatment including chemotherapy, radiotherapy, and immune therapy * never diagnosed of other malignancies * able to tolerate chemotherapy * ECOG≤2 * life expectance \>6 months * at least 1 measurable lesions(according to RECIST 1.1) * informed consent
Exclusion criteria
* pregnant or lactating women * participating in other clinical trials within 6 months * MSI-H or dMMR or EBER(+) * lesion located within 10cm from anal margin * severe liver dysfunction * severe renal dysfunction * cognitive disorder, mental disease or poor compliance * allergic to known chemotherapeutic agents * other conditions not suitable to participate in this trial determined by investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pathological complete response rate(pCR) | immediately evaluated after surgery | having no invasive cancer left in the resected sample |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate(ORR) | evaluated by imaging before surgery | CR+PR according to RECIST 1.1 |
| disease control rate(DCR) | evaluated by imaging before surgery | CR+PR+SD according to RECIST 1.1 |
| R0 resection rate | immediately evaluated after surgery | microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed |
| prediction accuracy of PTC | immediately evaluated after surgery | consistency between the effect of neoadjuvant chemotherapy and the result of PTC assay |
| pathological response rate | immediately evaluated after surgery | tumor regression grade 0-2 |
Contacts
Primary ContactAiwen Wu, M.D.
Outcome results
None listed