A Prospective, Single Center Clinical Study of Toripalimab Combined With FLOT Regimen for Periope… (NCT05466019) | Clinical Trial Compass
UnknownPhase 2
A Prospective, Single Center Clinical Study of Toripalimab Combined With FLOT Regimen for Perioperative Treatment of PD-L1 Positive Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GEJ)
China30 participantsStarted 2021-05-01
Plain-language summary
In this study, patients with PD-L1 positive locally advanced patients with resectable gastric cancer or gastroesophageal junction adenocarcinoma were invited to participate in the study.To evaluate the efficacy and safety of patients with PD-L1 positive gastric cancer or gastroesophageal junction adenocarcinoma (≥T3 and the number of lymph node metastasis ≥1, and No distant metastasis) using Toripalimab combined with docetaxel, oxaliplatin, fluorouracil, leucovorin (FLOT regimen) .
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Informed consent of the patient;
✓. 18 years old \<age \<75 years old;
✓. The researcher judged that he could comply with the study protocol;
✓. Histologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert II-III);
✓. Clinical stage at admission: ≥T3 with ≥1 lymph node metastasis and no distant metastasis (AJCC 8th)
✓. Immunohistochemistry confirmed that the patient was PD-L1 positive (CPS≥1);
✓. Preoperative ECOG \[Using the ECOG scoring standard Zubrod-ECOG-WHO (ZPS, 5-point method) developed by the Eastern Cooperative Oncology Group (ECOG)\] Physical State Score 0/1;
✓. Preoperative ASA score I-III;
Exclusion criteria
✕. Inestigators identified stage IV (metastatic) or unresectable gastric or gastroesophageal junction adenocarcinoma