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

NCT ID: NCT07304258

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-12
• Study Completion Date: 2027-12-31

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

Conditions

Gastric Cancer Peritoneal Metastases

Keywords

HIPEC; NIPS; PD-1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

Group Type: EXPERIMENTAL

HIPEC

Intervention Type: 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.

NIPS

Intervention Type: DEVICE

Paclitaxel Injection for intraperitoneal perfusion at a dose of 20mg/m² on D1 and D8; Q3W.

Paclitaxel Injection, S-1, tislelizumab

Intervention Type: 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.

Interventions

HIPEC

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.

Intervention Type: DEVICE

NIPS

Paclitaxel Injection for intraperitoneal perfusion at a dose of 20mg/m² on D1 and D8; Q3W.

Intervention Type: DEVICE

Paclitaxel 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Qun Zhao

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fourth Affiliated Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

Facility Contacts

Qun Zhao

Role: primary

Other Identifiers

HIPEC-NIPS-T Trial

Identifier Type: -

Identifier Source: org_study_id