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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIPEC | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Conversion Rate | Proportion of R0 Resection Patients in the ITT Population | The day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year PFS rate | Proportion of patients without disease progression or death for at least 1 year from treatment initiation | 1 year |
| 2-year OS rate | Proportion of patients surviving for at least 2 years from treatment initiation |
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Inclusion Criteria:
Exclusion Criteria:
Inability to comply with the study protocol or procedures;
Known HER2-positive status;
Known diagnosis of squamous cell carcinoma, undifferentiated carcinoma, or other histological types of gastric cancer, or adenocarcinoma mixed with other histological types;
Current conditions or diseases affecting drug absorption;
Patients preoperatively confirmed as unsuitable for conversion therapy;
Severe cardiovascular diseases, such as uncontrolled heart failure, coronary artery disease, arrhythmia, or uncontrolled hypertension;
Symptomatic active central nervous system metastases (e.g., clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth);
Known allergy to the investigational drug(s);
Prior treatment with anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, anti-CTLA-4 antibodies, or other drugs/antibodies targeting T-cell co-stimulation or checkpoint pathways;
Clinically uncontrolled active infections, such as acute pneumonia, active hepatitis B or C (HBV DNA ≥1×10⁴ copies/mL or >2000 IU/mL despite prior antiviral therapy); Known primary immunodeficiency or active tuberculosis; History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; Known history of human immunodeficiency virus (HIV) infection (HIV antibody positive);
Significant malnutrition (weight loss ≥5% within 1 month or >15% within 3 months prior to informed consent, or food intake reduced by ≥50% within 1 week), unless corrected for ≥4 weeks before the first dose of investigational drug;
History of other primary malignancies, except:
Female patients who are pregnant or breastfeeding;
Any concomitant illness that, in the investigator's judgment, seriously endangers patient safety or affects study completion;
Patients deemed ineligible for the study by the investigator.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fourth Affiliated Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
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| NIPS | Device | Paclitaxel Injection for intraperitoneal perfusion at a dose of 20mg/m² on D1 and D8; Q3W. |
|
| Paclitaxel Injection, S-1, tislelizumab | Drug | 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. |
|
| 2 years |
| Progression-free survival(PFS) | Time from enrollment to disease progression or death | 3 years |
| Overall survival (OS) | 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 | 3 years |
| ID | Term |
|---|---|
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| D017239 | Paclitaxel |
| C079198 | S 1 (combination) |
| C000707970 | tislelizumab |
| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D006979 | Hyperthermia, Induced |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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