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Not yet recruitingNCT07304258Updated Dec 26, 2025

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

A Phase 2 interventional study of HIPEC and NIPS in Gastric Cancer Peritoneal Metastases, sponsored by Hebei Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-26.

Sponsored by Hebei Medical University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

  • Gastric Cancer Peritoneal Metastases

Keywords

  • HIPEC
  • NIPS
  • PD-1
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Arm A

    Device: HIPEC · Device: NIPS · Drug: Paclitaxel Injection, S-1, tislelizumab

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.

05

What researchers measure

Primary outcomes

  1. Surgical Conversion Rate

    Proportion of R0 Resection Patients in the ITT Population

    Time frame: The day of surgery

Secondary outcomes

  1. 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. 2-year OS rate

    Proportion of patients surviving for at least 2 years from treatment initiation

    Time frame: 2 years

  3. Progression-free survival(PFS)

    Time from enrollment to disease progression or death

    Time frame: 3 years

  4. Overall survival (OS)

    Time frame: 3 years

  5. 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

06

Study locations

1 site
  • Fourth Affiliated Hospital of Hebei Medical University
    Shijiazhuang, Hebei, China
07

Registry details

Key details

Study ID
NCT07304258
Lead sponsor
Hebei Medical University
Responsible party
Qun Zhao (Principal Investigator, Hebei Medical University) — Principal investigator
First posted
Dec 26, 2025
Start date
Dec 12, 2025 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Dec 26, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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