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Brief Title: Toripalimab Plus FLOT in Locally Advanced Gastric Cancer
Official Title: Toripalimab Combined With FLOT Regimen in Locally Advanced Gastric cancer-a Prospective, Open, Single-center, Phase Ⅱ Clinical Study
Study ID: NCT04891016
Brief Summary: Neoadjuvant therapy for locally advanced gastric cancer is still in the exploratory stage. With the emergence of immune checkpoint inhibitors, neoadjuvant chemoimmunotherapy is also in the exploratory stage in locally advanced gastric cancer. At present, chemotherapy combined with immunotherapy is usually a simple combination of chemotherapeutic drugs and immune drugs, without taking into account of the influenece of applied sequence. The purpose of this study is to explore whether the sequence of chemotherapy and immunotherapy influence the complete pathological response rate in locally advanced gastric cancer.
Detailed Description: Neoadjuvant therapy for locally advanced gastric cancer is still in the exploratory stage. With the emergence of immune checkpoint inhibitors, neoadjuvant chemoimmunotherapy is also in the exploratory stage in locally advanced gastric cancer. At present, chemotherapy combined with immunotherapy is usually a simple combination of chemotherapeutic drugs and immune drugs, without taking into account of the influenece of applied sequence. The purpose of this study is to explore whether the sequence of chemotherapy and immunotherapy influence the complete pathological response rate in locally advanced gastric cancer. All patients received toripalimab plus FLOT regimen. If pCR was achieved, the patients received two cycles of toripalimab plus FLOT, then toripalimab maintenance until one year, if pCR was not achieved, the patients received 8 cycles of perioperative toripalimab plus FLOT, then toripalimab maintenance until one year.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, Henan, China
Name: Quanli Gao, M.D
Affiliation: Department of Immunotherapy, Henan Provincial Cancer Hospital
Role: PRINCIPAL_INVESTIGATOR