A Phase 2 interventional study of SOX+Sintilimab and FLOT+Sintilimab in Neoadjuvant Chemotherapy, Sintilimab and Locally Advanced Gastric Cancer, sponsored by Xijing Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-10.
Sponsored by Xijing Hospital · Phase 2, Interventional, and Treatment
This study aims to investigate the efficacy and safety of Sintilimab combined with FOLT versus Sintilimab combined with SOX in patients with locally advanced gastric cancer. The research design is intended to observe the comparison of conversion therapy effects, disease-free survival, R0 resection rate, and safety evaluation between the two groups.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 200 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.
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Exclusion Criteria:
Patients in the FLOT group received 4 cycles of standard FLOT chemotherapy, the FLOT chemotherapy cycle consists of: day 1: intravenous 5-FU 2600 mg/m² inserted through a peripherally inserted central catheter (PICC) for 24 hours intravenous folic acid 200 mg/m2 intravenous OXA 85 mg/m² intravenous TXT 50 mg/m². The next cycle of chemotherapy was repeated on day 15. Sintilimab: 200 mg every 3 weeks.
Drug: FLOT+Sintilimab
Patients in the SOX group received 3 cycles of S-1 + OXA chemotherapy prior to radical gastrectomy.The SOX chemotherapy cycle consists of: day 1: intravenous OXA 130 mg/m² days 1-14: oral S-1 80 mg/m², 2 times/Day. Repeat next chemotherapy on day 22. Sintilimab: 200 mg every 3 weeks.
Drug: SOX+Sintilimab
Patients would be allocated to the SOX+Sintilimab group.
Patients would be allocated to the FLOT+Sintilimab group.
The rate of radical (R0) resection after neoadjuvant therapy
efficacy of Sintilimab combined with FOLT versus Sintilimab combined with SOX in patients with locally advanced gastric cancer.
Time frame: From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days
adverse event
adverse event caused by FLOT, SOX or Sintilimab treatment, which were coded using the Medical Dictionary Regulatory Activities version 20.1 and adverse event grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events
Time frame: From the preoperative chemotherapy until the occurrence of adverse events, assessed up to 180 days
disease-free survival
from diagnosis to recurrence or death
Time frame: From date of diagnosis until the first documented recurrence or death, assessed up to 60 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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Xijing Hospital