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).
To evaluate the efficacy and quality of life in different treatment cohorts for patients with advanced gastric cancer and peritoneal metastasis. To evaluate the biodistribution and biological effects of PIPAV(Pressurized Intra-Peritoneal Aerosol Virus) treatment in patients with advanced gastric cancer and peritoneal metastasis, including viral distribution and shedding characteristics, as well as immunogenicity. To explore the relationship between pharmacodynamics, biomarkers, and therapeutic efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Doxorubicin (Adriamycin)
VRT106
No. 106, Zhongshan 2nd Road, Yuexiu District, Guangzhou
Guangzhou, Guangdong, China
Incidence of adverse events
Incidence of adverse events
Time frame: From the screening period to 28 days after the last intraperitoneal perfusion treatment during the follow-up period
Incidence of serious adverse events
Incidence of serious adverse events
Time frame: From the screening period to 28 days after the last intraperitoneal perfusion treatment during the follow-up period
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.
Time frame: From the screening period to 28 days after the last intraperitoneal perfusion treatment during the follow-up period
Surgical complications
Surgical complications
Time frame: From the screening period to 28 days after the last intraperitoneal perfusion treatment during the follow-up period
Postoperative pain score (Visual Analogue Scale/VAS score)
Scores of 1-3 are defined as "mild pain (sleep unaffected)"; 4-6 as "moderate pain (sleep affected)"; 7-10 as "severe pain (sleep severely affected)
Time frame: At the beginning of Cycle 1 (each cycle lasting 28 days), at the beginning of Cycle 2 (each cycle lasting 28 days), and at the beginning of Cycle 3 (each cycle lasting 28 days)
Peritoneal cancer index,PCI
0: No peritoneal metastasis; 1-2: Mild peritoneal metastasis; 3-4: Moderate peritoneal metastasis; 5-6: Severe peritoneal metastasis
Time frame: At the beginning of Cycle 1 (each cycle lasting 28 days), at the beginning of Cycle 2 (each cycle lasting 28 days), and at the beginning of Cycle 3 (each cycle lasting 28 days)
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
Time frame: At the beginning of Cycle 1 (each cycle lasting 28 days), at the beginning of Cycle 2 (each cycle lasting 28 days), and at the beginning of Cycle 3 (each cycle lasting 28 days).
Quality of life score
Quality of life score
Time frame: At the beginning of Cycle 1 (each cycle lasting 28 days), at the beginning of Cycle 2 (each cycle lasting 28 days), and at the beginning of Cycle 3 (each cycle lasting 28 days).
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