This study aims to evaluate the efficacy and safety of HIPEC combined with NIPS and tislelizumab conversion therapy for gastric/gastroesophageal junction cancer with positive cytology alone (CY1P0) or a Peritoneal Carcinomatosis Index (PCI) ≤10
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
HIPEC protocol: Paclitaxel Injection, 75mg/m², D1, D3, D5, for three cycles, followed by a two-week rest before initiating NIPS combined with systemic therapy.
Paclitaxel Injection for intraperitoneal perfusion at a dose of 20mg/m² on D1 and D8; Q3W.
Paclitaxel Injection: 50mg/m², iv, D1, D8; Q3W; Tegafur Gimeracil Oteracil Potassium Capsules (S-1):For body surface area (BSA) \<1.25, 40mg per dose; BSA ≥1.25 to \<1.5, 50mg per dose; BSA ≥1.5, 60mg per dose; po, bid, D1-D14; Q3W; Tislelizumab: 200mg per administration, intravenous drip over 30 minutes (not less than 20 minutes and not exceeding 60 minutes), D1, Q3W.
Fourth Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Surgical Conversion Rate
Proportion of R0 Resection Patients in the ITT Population
Time frame: The day of surgery
1-year PFS rate
Proportion of patients without disease progression or death for at least 1 year from treatment initiation
Time frame: 1 year
2-year OS rate
Proportion of patients surviving for at least 2 years from treatment initiation
Time frame: 2 years
Progression-free survival(PFS)
Time from enrollment to disease progression or death
Time frame: 3 years
Overall survival (OS)
Time frame: 3 years
Adverse events
Assessment of the incidence and severity of adverse events (AEs) and serious adverse events (SAEs) according to the NCI-CTCAE v5.0 criteria; abnormalities in vital signs and laboratory tests
Time frame: 3 years
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