Gastric Cancer Peritoneal Metastases
Conditions
Keywords
HIPEC, NIPS, PD-1
Brief summary
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
Interventions
DEVICEHIPEC
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.
DEVICENIPS
Paclitaxel Injection for intraperitoneal perfusion at a dose of 20mg/m² on D1 and D8; Q3W.
DRUGPaclitaxel Injection, S-1, tislelizumab
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.
Sponsors
Hebei Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Treatment-naïve patients who have not received chemotherapy, radiotherapy, or any other antitumor therapy prior to the start of the clinical trial; 2. Age between 18 and 75 years; 3. Male or non-pregnant, non-lactating female; 4. Gastric or gastroesophageal junction adenocarcinoma confirmed by gastroscopy and pathological diagnosis; 5. HER-2 negative by immunohistochemistry (IHC), and PD-L1 CPS ≥1; 6. Laparoscopic exploration confirming either positive cytology alone (P0CY1) or peritoneal metastasis (PCI score ≤10); 7. No other distant metastases; 8. Hematological criteria: white blood cell count ≥3.5×10⁹/L, neutrophils ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L; 9. Biochemical criteria: ALT ≤2.5×ULN, AST ≤2.5×ULN, total bilirubin ≤1.5×ULN, serum creatinine ≤1.5×ULN; 10. Left ventricular ejection fraction ≥50%; 11. ECOG performance status 0-1; 12. Ability to comply with the study protocol and voluntarily provide signed informed consent.
Exclusion criteria
1. Inability to comply with the study protocol or procedures; 2. Known HER2-positive status; 3. Known diagnosis of squamous cell carcinoma, undifferentiated carcinoma, or other histological types of gastric cancer, or adenocarcinoma mixed with other histological types; 4. Current conditions or diseases affecting drug absorption; 5. Patients preoperatively confirmed as unsuitable for conversion therapy; 6. Severe cardiovascular diseases, such as uncontrolled heart failure, coronary artery disease, arrhythmia, or uncontrolled hypertension; 7. Symptomatic active central nervous system metastases (e.g., clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth); 8. Known allergy to the investigational drug(s); 9. 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; 10. 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); 11. 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; 12. History of other primary malignancies, except: * Malignancies in complete remission for at least 2 years prior to enrollment with no required treatment during the study; * Adequately treated non-melanoma skin cancer or malignant lentigo with no evidence of recurrence; * Adequately treated carcinoma in situ with no evidence of recurrence; 13. Female patients who are pregnant or breastfeeding; 14. Any concomitant illness that, in the investigator's judgment, seriously endangers patient safety or affects study completion; 15. Patients deemed ineligible for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Conversion Rate | The day of surgery | Proportion of R0 Resection Patients in the ITT Population |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1-year PFS rate | 1 year | Proportion of patients without disease progression or death for at least 1 year from treatment initiation |
| 2-year OS rate | 2 years | Proportion of patients surviving for at least 2 years from treatment initiation |
| Progression-free survival（PFS） | 3 years | Time from enrollment to disease progression or death |
| Overall survival (OS) | 3 years | — |
| Adverse events | 3 years | 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 |
Countries
China
Outcome results
None listed