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The Efficacy and Safety of HIPEC Combined With PD-1 and SOX Chemotherapy for the Translational Treatment of GC or EGJC With PM

NCT06427252 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-07-16

No results posted yet for this study

Summary

Gastric cancer (GC) with peritoneal metastasis has a poor prognosis and short survival. In recent years, heat intraperitoneal perfusion chemotherapy (HIPEC) has gained better efficacy in the treatment of peritoneal metastases of many malignant tumors, including GC with peritoneal metastasis. The use of immune checkpoint inhibitors (ICIs) in the treatment of advanced GC has made significant progress in recent years. And studies showed that patients who were responded to immunotherapy combined with chemotherapy as the first-line treatment were able to achieve significant survival benefit after radical resection. However, whether HIPEC combined with immunotherapy for peritoneal metastatic gastric cancer improves the R0 resection rate and prolongs survival time is currently unclear. Therefore, we conducted this prospective multicenter clinical trial to explore the effective dose and safety of the combination of systemic chemotherapy, HIPEC, anti-PD-1 and anti-HER-2 therapy, which will provide a clinical basis for the treatment of advanced GC.

Conditions

  • Gastric Cancer, Metastatic

Interventions

DRUG

HIPEC

In the experimental group, HIPEC treatment (paclitaxel, 3000 ml of physiological saline at 43°C for 60 min) was performed on the first day after the first exploratory laparotomy and on the third day after the radical surgery for a total of 2-3 times (total amount of paclitaxel was 175 mg/m2 ), with an interval of not more than 72 h. Intravenous systemic therapy was started 3 weeks after the completion of HIPEC treatment. systemic therapy.

DRUG

Systemic therapy

1. Tirilizumab: 200 mg, i.v., D1, Q3W; 2. oxaliplatin: 130mg/m2, i.v., D1, Q3W; 3. Herceptin: a tri-weekly dosing regimen with an initial loading dose of 8 mg/kg followed by 6 mg/kg Q3W. 4. Tegeo: Oral administration: 40 mg per dose for BSA \<1.25, 50 mg per dose for BSA 1.25 to 1.5, and 60 mg per dose for BSA ≥1.5, twice daily for each treatment cycle D1-D14, Q3W;

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Zekuan Xu, PhD · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2026-05-31
Completion
2027-05-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06427252 on ClinicalTrials.gov