NCT06371586

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Cancer
• Diffuse Type Carcinoma

Interventions

Type	Name	Description
DRUG	Albumin 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.

Timeline

• Start date: 2024-03-01
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2024-04-17
• Last updated: 2024-04-17

Locations

1 site across 1 country: China