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Gastric Cancer Peritoneal MetastasesPhase 2NCT07304258

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 study testing HIPEC, NIPS and Paclitaxel Injection, S-1, tislelizumab in people with Gastric Cancer Peritoneal Metastases, run by Hebei Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Cancer Peritoneal Metastases
What is being tested?
HIPEC, NIPS and Paclitaxel Injection, S-1, tislelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
12 Dec 2025to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Treatment-naïve patients who have not received chemotherapy, radiotherapy, or any other antitumor therapy prior to the start of the clinical trial;
  • Age between 18 and 75 years;
  • Male or non-pregnant, non-lactating female;
  • Gastric or gastroesophageal junction adenocarcinoma confirmed by gastroscopy and pathological diagnosis;
  • HER-2 negative by immunohistochemistry (IHC), and PD-L1 CPS ≥1;
  • Laparoscopic exploration confirming either positive cytology alone (P0CY1) or peritoneal metastasis (PCI score ≤10);
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  • No other distant metastases;
  • Hematological criteria: white blood cell count ≥3.5×10⁹/L, neutrophils ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L;
  • Biochemical criteria: ALT ≤2.5×ULN, AST ≤2.5×ULN, total bilirubin ≤1.5×ULN, serum creatinine ≤1.5×ULN;
  • Left ventricular ejection fraction ≥50%;
  • ECOG performance status 0-1;
  • Ability to comply with the study protocol and voluntarily provide signed informed consent.

Who cannot join

  • Inability to comply with the study protocol or procedures;
  • Known HER2-positive status;
  • Known diagnosis of squamous cell carcinoma, undifferentiated carcinoma, or other histological types of gastric cancer, or adenocarcinoma mixed with other histological types;
  • Current conditions or diseases affecting drug absorption;
  • Patients preoperatively confirmed as unsuitable for conversion therapy;
  • Severe cardiovascular diseases, such as uncontrolled heart failure, coronary artery disease, arrhythmia, or uncontrolled hypertension;
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  • Symptomatic active central nervous system metastases (e.g., clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth);
  • Known allergy to the investigational drug(s);
  • 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;
  • 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);
  • 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;
  • 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;
  • Female patients who are pregnant or breastfeeding;
  • Any concomitant illness that, in the investigator's judgment, seriously endangers patient safety or affects study completion;
  • Patients deemed ineligible for the study by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Fourth Affiliated Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Qun Zhao, 13930162111, zhaoqun516@126.com

Other trials in China

About this study

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

Being tested
HIPEC, NIPS, Paclitaxel Injection, S-1, tislelizumab
Keywords
HIPEC, NIPS, PD-1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HIPECDevice

    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.

  • NIPSDevice

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

  • Paclitaxel Injection, S-1, tislelizumabDrug

    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.

Study groups in NCT07304258
Study groupRoleWhat they receive
Arm AExperimentalNot described
Receives: Device: HIPEC; Device: NIPS; Drug: Paclitaxel Injection, S-1, tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Surgical Conversion Rate

    Proportion of R0 Resection Patients in the ITT Population

    Measured: The day of surgery

Secondary outcomes (5)

  1. 1-year PFS rate

    Proportion of patients without disease progression or death for at least 1 year from treatment initiation

    Measured: 1 year

  2. 2-year OS rate

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

    Measured: 2 years

  3. Progression-free survival（PFS）

    Time from enrollment to disease progression or death

    Measured: 3 years

  4. Overall survival (OS)

    Measured: 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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2025
  2. Study start12 Dec 2025 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07304258
Sponsor's protocol ID
HIPEC-NIPS-T Trial
Status last verified
Dec 2025
First submitted
12 Dec 2025
Last updated
26 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HIPEC, NIPS and Paclitaxel Injection, S-1, tislelizumab in people with Gastric Cancer Peritoneal Metastases, run by Hebei Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical Conversion Rate (time frame: The day of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07304258.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.

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