Neo-Sequence 2：NCT Plus Anti-angiogenesis Therapy and Immunotherapy for LADGC
Neo-Sequence 2：Phase 2 Study of Neoadjuvant Chemotherapy Plus Anti-angiogenesis Therapy and Immunotherapy for Locally Advanced Diffuse Gastric Cancer
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
67 participants
Mar 1, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria10
- Local advanced diffuse or mixed type gastric cancer detected by pathology and endoscopy;
- 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);
- Has not received any anti-tumor treatment for gastric cancer yet;
- Age range from 18 to 75 years old;
- ECOG score 0-1 points;
- 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;
- Left ventricular ejection fraction\>60%;
- Good compliance and ability to accept long-term follow-up;
- Sign informed consent.
Exclusion Criteria11
- Gastrointestinal obstruction or recurrent bleeding cannot be controlled;
- Those who cannot swallow pills;
- Diagnose immunodeficiency or active autoimmune diseases, have received or are currently receiving immunomodulators, systemic steroid therapy, or immunosuppressive drugs within the past two years;
- Interstitial pneumonia;
- Moderate to severe cirrhosis caused by any reason;
- Uncontrollable hypertension, severe kidney disease, and significant cardiovascular and cerebrovascular diseases;
- Active infections that require systemic treatment;
- Previously suffered from other tumors, excluding cured skin cancer and cervical cancer in situ;
- Internal medicine diseases that do not meet the chemotherapy criteria at the same time;
- Pregnant and lactating patients;
- Individuals with a history of mental illness and poor compliance.
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06371586