Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:56 AM
Study NCT ID:
NCT07304258
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-26
First Post:
2025-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Phase II Clinical Study of HIPEC Combined With NIPS and Tislelizumab Conversion Therapy for Gastric Cancer With Peritoneal Metastasis With Positive Cytology Alone or PCI Score ≤10
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000084262', 'term': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'C079198', 'term': 'S 1 (combination)'}, {'id': 'C000707970', 'term': 'tislelizumab'}], 'ancestors': [{'id': 'D017024', 'term': 'Chemotherapy, Adjuvant'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2025-12-12', 'studyFirstSubmitQcDate': '2025-12-12', 'lastUpdatePostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Conversion Rate', 'timeFrame': 'The day of surgery', 'description': 'Proportion of R0 Resection Patients in the ITT Population'}], 'secondaryOutcomes': [{'measure': '1-year PFS rate', 'timeFrame': '1 year', 'description': 'Proportion of patients without disease progression or death for at least 1 year from treatment initiation'}, {'measure': '2-year OS rate', 'timeFrame': '2 years', 'description': 'Proportion of patients surviving for at least 2 years from treatment initiation'}, {'measure': 'Progression-free survival（PFS）', 'timeFrame': '3 years', 'description': 'Time from enrollment to disease progression or death'}, {'measure': 'Overall survival (OS)', 'timeFrame': '3 years'}, {'measure': 'Adverse events', 'timeFrame': '3 years', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIPEC', 'NIPS', 'PD-1'], 'conditions': ['Gastric Cancer Peritoneal Metastases']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Treatment-naïve patients who have not received chemotherapy, radiotherapy, or any other antitumor therapy prior to the start of the clinical trial;\n2. Age between 18 and 75 years;\n3. Male or non-pregnant, non-lactating female;\n4. Gastric or gastroesophageal junction adenocarcinoma confirmed by gastroscopy and pathological diagnosis;\n5. HER-2 negative by immunohistochemistry (IHC), and PD-L1 CPS ≥1;\n6. Laparoscopic exploration confirming either positive cytology alone (P0CY1) or peritoneal metastasis (PCI score ≤10);\n7. No other distant metastases;\n8. Hematological criteria: white blood cell count ≥3.5×10⁹/L, neutrophils ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L;\n9. Biochemical criteria: ALT ≤2.5×ULN, AST ≤2.5×ULN, total bilirubin ≤1.5×ULN, serum creatinine ≤1.5×ULN;\n10. Left ventricular ejection fraction ≥50%;\n11. ECOG performance status 0-1;\n12. Ability to comply with the study protocol and voluntarily provide signed informed consent.\n\nExclusion Criteria:\n\n1. Inability to comply with the study protocol or procedures;\n2. Known HER2-positive status;\n3. Known diagnosis of squamous cell carcinoma, undifferentiated carcinoma, or other histological types of gastric cancer, or adenocarcinoma mixed with other histological types;\n4. Current conditions or diseases affecting drug absorption;\n5. Patients preoperatively confirmed as unsuitable for conversion therapy;\n6. Severe cardiovascular diseases, such as uncontrolled heart failure, coronary artery disease, arrhythmia, or uncontrolled hypertension;\n7. Symptomatic active central nervous system metastases (e.g., clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth);\n8. Known allergy to the investigational drug(s);\n9. 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;\n10. 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);\n11. 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;\n12. History of other primary malignancies, except:\n\n * Malignancies in complete remission for at least 2 years prior to enrollment with no required treatment during the study;\n * Adequately treated non-melanoma skin cancer or malignant lentigo with no evidence of recurrence;\n * Adequately treated carcinoma in situ with no evidence of recurrence;\n13. Female patients who are pregnant or breastfeeding;\n14. Any concomitant illness that, in the investigator's judgment, seriously endangers patient safety or affects study completion;\n15. Patients deemed ineligible for the study by the investigator."}, 'identificationModule': {'nctId': 'NCT07304258', 'briefTitle': 'A Prospective, Phase II Clinical Study of HIPEC Combined With NIPS and Tislelizumab Conversion Therapy for Gastric Cancer With Peritoneal Metastasis With Positive Cytology Alone or PCI Score ≤10', 'organization': {'class': 'OTHER', 'fullName': 'Hebei Medical University'}, 'officialTitle': 'A Prospective, Phase II Clinical Study of HIPEC Combined With NIPS and Tislelizumab Conversion Therapy for Gastric Cancer With Peritoneal Metastasis With Positive Cytology Alone or PCI Score ≤10', 'orgStudyIdInfo': {'id': 'HIPEC-NIPS-T Trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'interventionNames': ['Device: HIPEC', 'Device: NIPS', 'Drug: Paclitaxel Injection, S-1, tislelizumab']}], 'interventions': [{'name': 'HIPEC', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Arm A']}, {'name': 'NIPS', 'type': 'DEVICE', 'description': 'Paclitaxel Injection for intraperitoneal perfusion at a dose of 20mg/m² on D1 and D8; Q3W.', 'armGroupLabels': ['Arm A']}, {'name': 'Paclitaxel Injection, S-1, tislelizumab', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Arm A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'contacts': [{'name': 'Qun Zhao', 'role': 'CONTACT', 'email': 'zhaoqun516@126.com', 'phone': '13930162111'}], 'facility': 'Fourth Affiliated Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebei Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Qun Zhao', 'investigatorAffiliation': 'Hebei Medical University'}}}}