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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

ConditionGastric Cancer Peritoneal Metastases
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHebei Medical University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • HIPEC

    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

    Device

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

  • Paclitaxel Injection, S-1, tislelizumab

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Arm AExperimental treatment 3 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hebei Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: