Clinical trial · Interventional
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
NCT07304258CI-TRIAL-00099685not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer Peritoneal Metastases | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HIPEC | Device | — | UNRESOLVED |
| NIPS | Device | — | UNRESOLVED |
| Paclitaxel Injection, S-1, tislelizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm A
- interventionNames
- Device: HIPEC
- Device: NIPS
- Drug: Paclitaxel Injection, S-1, tislelizumab
Primary outcomes (1)
- measure
- Surgical Conversion Rate
- timeFrame
- The day of surgery
- description
- Proportion of R0 Resection Patients in the ITT Population
Secondary outcomes (5)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.References
Publications (0)
Data not yet available
No reference posted for this study.