gastric cancer
Conditions
Interventions
Gold Standard:Evaluation of the effect of adjuvant therapy before tumor surgery (tumor regression grading)
Grade 0 (complete regression): no residual tumor cells (including lymph nodes, stage ypT0N0CM
Index test:Results of protein profiling and molecular typing of paraffin-embedded sections of gastric cancer tissue
Sponsors
General Hospital of the People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years old, patients with gastric cancer confirmed by preoperative pathology; 2. "2021 CSCO Gastric Cancer Treatment Guidelines" staging cT3-4aNxM0 gastric cancer patients who need neoadjuvant chemotherapy; 3. All patients have not received adjuvant radiotherapy and chemotherapy before; 4. The provided paraffin-embedded section specimens show that the tumor cell content is greater than 5% in hematoxylin and eosin (HE) staining; 5. The patients whose paraffin-embedded section specimens provided more than or equal to 700 proteins in the protein profile detection; 6. Physical condition and organ function allow >=3 cycles of chemotherapy and major abdominal surgery; 7. Willingness and ability to comply with the protocol during the study; 8. Expected survival > 6 months; 9. No other serious concomitant diseases and good organ function; 10. No medical contraindications that seriously affect anesthesia and surgery.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women, those who are in the reproductive period and have not taken effective contraceptive measures; 2. Concomitant serious medical disease or condition: such as clinically serious (ie active) heart disease, serious, uncontrolled medical disease, and infection, severe uncontrolled digestive disturbance, severe electrolyte disturbance, active dissemination Intravascular coagulation, major organ failure, such as decompensated heart, lung, liver, kidney failure, symptomatic peripheral neuropathy, etc., cannot tolerate chemotherapy and surgery; 3. Those who need immunosuppressive therapy for organ transplantation; 4. Severe uncontrolled recurrent infection, or other serious uncontrolled concomitant disease; 5. History of other malignant tumors within 5 years after the start of the trial, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; 6. Patients with no self-awareness and mental disorders; 7. Have a history of organ transplantation (including bone marrow autologous transplantation and peripheral stem cell transplantation); 8. Concurrent use of other experimental drugs or other clinical trials; 9. Those who have received biological therapy or other anti-cancer traditional Chinese medicines with an interval of fewer than 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Evaluation Criteria in Solid Tumors, RECIST;Tumor regression grade, TRG; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Intraoperative blood loss;The operation time;Postoperative exhaust time;Postoperative hospital stay;Short-term postoperative complications;Long-term postoperative complications; | — |
Countries
China
Contacts
Public ContactZhang Kecheng
Chinese General Hospital of the People's Liberation Army (PLAGH)
Outcome results
None listed