Consistency Between Treatment Responses in PDO Models and Clinical Outcomes in Gastric Cancer

D1 Medical Technology

Status

Unknown

Conditions

Gastric Cancer

Treatments

Procedure: Tumor biopsy

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05203549

D1med-GC1001

Details and patient eligibility

About

Gastric cancer is the fourth leading cause of cancer-related death worldwide. Accurate assessment of the clinical responses to current treatment regimens is key to improving the prognosis and prolonging the survival of patients. In this study, two hundred and fifty patients with gastric cancer who ought to receive neoadjuvant therapy, conversion therapy or palliative chemotherapy will be enrolled, and patient-derived organoids from their tumor biopsies will be used to test the sensitivity of chemotherapy drugs which mainly include 5-fluorouracil, irinotecan, oxaliplatin and paclitaxel.

Full description

Two hundred and fifty stage II-IV gastric cancer patients who should receive neoadjuvant therapy, conversion therapy or palliative chemotherapy will be enrolled in this study. Baseline information of the enrolled patients including medical history, physical examination records and clinical examination records will be collected. Tumor material of those patients will be obtained from gastric endoscopic biopsies or surgical resection. Patient-derived organoids (PDOs) will be established and cultured from gastric cancer tumor specimens. PDOs will then be treated with drugs of the chemotherapeutic regimens for gastric cancer. Organoid size and growth will be monitored before and after the treatment, and dose-response curves will be generated. As for the assessment of clinical outcomes of patients, tumor regression grade (TRG) systems will be used to evaluate tumor histological responses, and treatment responses will also be assessed by biomedical imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST1.1). Consistency between treatment responses in PDO models and clinical outcomes of patients will be assessed by correlation analysis.

Enrollment

250 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age from 18 to 70 years old, no gender limit
The primary tumor is diagnosed as gastric adenocarcinoma (papillary, tubular, signet ring cell, poorly differentiated and mucinous adenocarcinoma) by endoscopic biopsy sampling and follow-up histopathological staining
The pre-operative staging includes: a) Stage IVa（cT4bNanyM0），resectable; b) Stage II-III（cT1-2N1-3M0、cT3-4aN0-3M0）, gastro-oesophageal junction (GEJ) cancer；c) Stage III（cT3-4aN1-3M0）, non-GEJ cancer, appropriate for neoadjuvant therapy
Stage IVb or locally unresectable late-stage gastric or GEJ cancer, previously never received chemotherapy
Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
The function of major organs is normal, meeting the following criteria: a) routine blood tests (no blood transfusion in the past 14 days): HB≥90g/L；ANC ≥1.5×109/L；PLT ≥80×109/L；b）blood biochemical parameters: BIL <1.5-fold upper limit of normal (ULN)；ALT<2.5×ULN; AST<2.5×ULN；Crea≤1×ULN
Fresh tumor tissue biopsies are obtainable and the clinical information of the patients is complete
Patients have been informed and consented

Exclusion criteria

Previously received neoadjuvant therapy
Previously had other types of malignancy and received chemotherapy or radiotherapy
Previously had chicken pox, herpes zoster or other severe contagious diseases
Have severe active ulcer (gastrointestinal tract, skin, etc.) or have developed a high fever
Have a medical history of myocardial infarction, cerebral infarction, or pulmonary embolism
Have complications of gastric cancer (bleeding, perforation and obstruction etc.) and need emergency operation
Pregnant or lactating women
Have severe mental diseases
Allergic to chemotherapy drugs
Have metastatic brain cancer
Refuse to cooperate and to complete a treatment