This study is a prospective, multicenter, open-label, randomized controlled clinical trial, planned to enroll 30 patients with advanced gastric cancer and peritoneal metastasis. It aims to evaluate the safety and efficacy of systemic therapy plus Pressurized Intra-Peritoneal Aerosol Virus (PIPAV) with VRT106 compared to systemic therapy plus Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC).
Aged 18 to 75 years, inclusive, regardless of gender.
Histologically or pathologically confirmed gastric adenocarcinoma with peritoneal metastasis (confirmed by imaging findings, previous surgical pathology, or positive cytology from ascites/peritoneal fluid), and assessed by the investigator as having unresectable peritoneal lesions with a PCI score > 6.
Subjects with no contraindications for laparoscopic surgery.
ECOG performance status ≤ 1.
Use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroids;
Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- or third-degree atrioventricular block, QT interval corrected using Fridericia's formula (QTcF) ≥ 480 ms, etc.;
Occurrence of acute coronary syndrome, acute myocardial infarction, congestive heart failure, stroke, or other Grade 3 or higher cardiovascular events within 6 months prior to the first dose of the study drug;
New York Heart Association (NYHA) functional class ≥ II, or left ventricular ejection fraction (LVEF) < 50%;
Factorial
Doxorubicin (Adriamycin)
DrugDoxorubicin (Adriamycin)
VRT106
DrugVRT106
Incidence of adverse events
Incidence of adverse events
Incidence of serious adverse events
Incidence of serious adverse events
Eastern Cooperative Oncology Group Performance status
0 - Fully active, able to carry on all pre-disease performance without restriction. 1. \- Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours. 3. \- Capable of only limited self-care; confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled; cannot carry on any self-care; totally confined to bed or chair. 5. \- Dead.
Surgical complications
Surgical complications
Peritoneal cancer index，PCI
0: No peritoneal metastasis; 1-2: Mild peritoneal metastasis; 3-4: Moderate peritoneal metastasis; 5-6: Severe peritoneal metastasis
Peritoneal regression grading score，PRGS
PRGS 1 - Complete Response No residual tumor cells Extensive fibrosis / gelatinous mucin pools / infarct-like necrosis PRGS 2 - Major Changes Predominantly regressive changes in tumor cells Fibrosis / gelatinous mucin pools / Tumor cells predominantly with infarct-like necrosis PRGS 3 - Minor Changes Tumor cells predominate, significantly more than regressive changes Tumor cells clearly dominate, more than fibrosis / gelatinous mucin pools / infarct-like necrosis PRGS 4 - No Changes Steady growth of tumor cells (visible at lowest magnification) No regressive changes
Quality of life score
Quality of life score
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