Toripalimab Combined With FLOT Neoadjuvant Chemotherapy in Patients With Resectable Gastric Cancer
Status:
Recruiting
Trial end date:
2024-06-30
Target enrollment:
Participant gender:
Summary
Gastric cancer is one of the most common malignant tumors of the digestive tract. Gastric
cancer patients diagnosed for the first time in China have a higher proportion of advanced
stages and a higher postoperative metastasis rate. Studies have shown that patients with good
pathological response after preoperative neoadjuvant therapy (such as tumor regression grade,
TRG0 or 1) have a better prognosis. The AIO-FLOT4 study found that preoperative perioperative
FLOT chemotherapy not only prolonged the progression-free survival (PFS) time and overall
survival (OS) time of patients with advanced gastric cancer, but also increased postoperative
pathological remission rate. How to further improve the efficacy of the perioperative
treatment plan may be beneficial to improve the long-term survival of gastric cancer
patients. Several clinical studies have also confirmed that PD-1 antibody significantly
prolongs the life of gastric cancer patients who have failed advanced chemotherapy in the
back-line treatment. Thus the investigators plan to conduct this clinical trials to evaluate
the safety and efficacy of Toripalimab (PD-1 antibody) combined with FLOT regimen in the
perioperative period.The secondary end points included pathological remission rate, resection
rate, D2 radical resection rate, 5-year disease-free survival (DFS) rate and 5-year OS rate.
Phase:
Phase 2
Details
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital