Diffuse Type Carcinoma, Gastric Cancer
Conditions
Brief summary
The regimen of Albumin paclitaxel+SOX+BEV neoadjuvant therapy lasted for 6 cycles, during which PD-1 monoclonal antibody therapy was interspersed for 4 cycles for locally advanced diffuse gastric cancer.
Detailed description
The biweekly regimen of Albumin paclitaxel+SOX+BEV neoadjuvant therapy lasted for 6 cycles, during which PD-1 monoclonal antibody therapy was interspersed for 4 cycles. Review CT and gastroscopy every 3 cycles to evaluate the therapeutic effect. Patients who have been evaluated as effective after 6 cycles of treatment may consider surgery; Or continue the dual cycle regimen ofAlbumin paclitaxel+Bevacizumab for 3 cycles, while PD-1 monoclonal antibody for 2 cycles. Afterwards, the therapeutic effect will be evaluated, and surgery, radiotherapy, or maintenance medication treatment will be determined based on the therapeutic effect. Surgical patients begin adjuvant treatment 1-2 months after surgery based on the curative and pathological results of the surgery. Those who fail to evaluate during neoadjuvant therapy will undergo surgery or radiation therapy, or switch to a second-line systemic treatment plan.
Interventions
DRUGAlbumin paclitaxel+SOX+BEV+ PD-1 monoclonal antibody therapy
Albumin paclitaxel+SOX+BEV bi weekly neoadjuvant therapy for 6 cycles, with PD-1 monoclonal antibody therapy interspersed for 4 cycles. Review CT and gastroscopy every 3 cycles to evaluate the therapeutic effect. Patients who have been evaluated as effective after 6 cycles of treatment may consider surgery; Or continue the two-week regimen of albumin paclitaxel+bevacizumab for 3 cycles, while PD-1 monoclonal antibody for 2 cycles. Afterwards, the therapeutic effect will be evaluated, and surgery, radiotherapy, or maintenance medication treatment will be determined based on the therapeutic effect. Surgical patients begin adjuvant treatment 1-2 months after surgery based on the curative and pathological results of the surgery. Those who fail to evaluate during neoadjuvant therapy will undergo surgery or radiation therapy, or switch to a second-line systemic treatment plan.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Local advanced diffuse or mixed type gastric cancer detected by pathology and endoscopy; 2. Chest, abdomen, and pelvis enhanced CT, neck and supraclavicular ultrasound, gastroscopy, and endoscopic ultrasound were used to diagnose T3-4NanyM0 gastric cancer or gastroesophageal junction cancer (refer to AJCC staging, 8th edition); 3. Has not received any anti-tumor treatment for gastric cancer yet; 4. Age range from 18 to 75 years old; 5. ECOG score 0-1 points; 6. Liver and kidney function and blood routine meet the following conditions: Neutrophils\>1.5G/L, Hb\>90g/L, PLT\>100G/L; ALT and AST\<2.5ULN; TBIL\<1.5 ULN; Cr\<1.0ULN; 7. Left ventricular ejection fraction\>60%; 8. Good compliance and ability to accept long-term follow-up; 9. Sign informed consent.
Exclusion criteria
1. Gastrointestinal obstruction or recurrent bleeding cannot be controlled; 2. Those who cannot swallow pills; 3. Diagnose immunodeficiency or active autoimmune diseases, have received or are currently receiving immunomodulators, systemic steroid therapy, or immunosuppressive drugs within the past two years; 4. Interstitial pneumonia; 5. Moderate to severe cirrhosis caused by any reason; 6. Uncontrollable hypertension, severe kidney disease, and significant cardiovascular and cerebrovascular diseases; 7. Active infections that require systemic treatment; 8. Previously suffered from other tumors, excluding cured skin cancer and cervical cancer in situ; 9. Internal medicine diseases that do not meet the chemotherapy criteria at the same time; 10. Pregnant and lactating patients; 11. Individuals with a history of mental illness and poor compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological response rate | 3 year | No residual cancer cells |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EFS | 3 year | event free survival |
| OS | 3 year | overall survival |
| R0 | 3 year | Negative margin of incision |
| Safety (adverse events) and surgical complications | 3 year | Chemotherapy side effects and surgical safety |
Countries
China
Contacts
Primary ContactChunxia Du, MD
Outcome results
None listed