PD-1 Blockade With JS001 Plus Neoadjuvant Chemotherapy for Gastric/Gastroesophageal Junction Cancer
Status:
Not yet recruiting
Trial end date:
2024-09-30
Target enrollment:
Participant gender:
Summary
Gastric cancer (GC),including cardia and noncardia gastric cancer, is responsible for over
480,000 new cases in 2020 and an estimated 370,000 deaths, making it the third most
frequently diagnosed cancer and the third leading cause of cancer death in China. Majority of
patients(63%) are presented with locally advanced gastric cancer (stage Ⅱ/Ⅲ) and the
prognosis is poor. Previous studies have shown that patients with pathological complete
response(pCR) following neoadjuvant therapy have longer survival. In 2019, Lancet Oncology
published the FLOT4-AIO study which testified that perioperative chemotherapy with FLOT
(5-FU/LV, oxaliplatin and docetaxel) regimen has improved pCR rate and prolonged progression
free survival(PFS) and overall survival(OS) in patients with stage II/III gastric cancer.
Moreover, PD-1 blockade such as nivolumab or pembrolizumab in combination with chemotherapy
has shown higher objective response rate(ORR) as compared to chemotherapy alone in advanced
gastric cancer. The nanoparticle albumin-bound paclitaxel has been recommended as the
second-line chemotherapy for unresectable or recurrent gastric cancer based on the Chinese
Society of Clinical Oncology(CSCO) guideline. When PD-1 antibody is applied, albumin-bound
paclitaxel is considered as a better partner since no pretreatment of corticosteroids is
needed. Thus, the investigators plan to conduct a phase II clinical trial to evaluate the
efficacy and safety of toripalimab (PD-1 antibody) combined with the FLOAP (albumin-bound
paclitaxel, oxaliplatin, fluorouracil and leucovorin) regimen as the perioperative treatment
of cT2-4 and/or N+ GC. The primary end point is pCR rate. The secondary end points include
disease free survival(DFS), OS, ORR, R0 resection rate, incidence of adverse events(AE).