Locally Advanced Gastric Cancer
Conditions
Interventions
Observation Group (Neoadjuvant chemotherapy followed by surgery):None
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Entry Criteria 1. aged 18 years and above; 2. diagnosed with locally progressive gastric adenocarcinoma by histopathology or cytology and imaging; 3. preoperative imaging assessment of T4b possible, assessed by the surgeon as difficult or impossible to R0 resection, receiving preoperative neoadjuvant immunotherapy combination therapy followed by surgery; or participating in a clinical study, receiving preoperative neoadjuvant immunotherapy combination therapy followed by surgery; or receiving neoadjuvant immunotherapy combination therapy followed by surgery, etc., after MDT; or preoperative imaging suggestive of locally progressive gastric adenocarcinoma (cT2-4aN+M0) receiving Surgery after preoperative neoadjuvant chemotherapy; 4. complete records of neoadjuvant therapy, including imaging data before and after the start of therapy, laboratory test results and detailed information during the course of therapy; 5. Surgery after neoadjuvant therapy or other standard follow-up treatment as appropriate; 6. expected survival > 3 months; 7. the medical records contain sufficient follow-up information to evaluate efficacy and safety; 8. the subject gives informed consent and voluntarily cooperates with the clinical follow-up by signing an informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. previous systemic anti-tumour therapy (excluding neoadjuvant therapy); 2. the presence of unresectable distant metastases (M1 stage) or localised lesions that cannot be managed by surgery; 3. have a combination of severe uncontrolled cardiac, pulmonary, hepatic, renal and other vital organ dysfunction or disease, which affects the tolerance of treatment or survival prognosis; 4. active infection, autoimmune disease or other serious complications that are contraindications to immunotherapy or interfere with the assessment of the efficacy or safety of immunotherapy; 5. the patient is unwilling to participate in the study for personal reasons or is unable to provide informed consent; 6. severe neurological or haematological disease exists during or before neoadjuvant therapy, or specific contraindications to the use of immunotherapy exist; 7. expected survival of less than one year due to other non-gastric cancer related reasons; 8. combination of other malignant tumours, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;R0 excision rate;DFS;OS;Adverse event rate; | — |
Countries
China
Contacts
Public ContactZhouwei Zhan
Fujian cancer hospital
Outcome results
None listed