Evaluation of Pressurized Intraperitoneal Aerosol Chemotherapy With VRT106 Versus PIPAC in Patien… (NCT07486310) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Evaluation of Pressurized Intraperitoneal Aerosol Chemotherapy With VRT106 Versus PIPAC in Patients With Advanced Gastric Cancer and PeritonealMetastasis: A Prospective, Multicenter, Open-Label, Randomized Controlled Trial
China30 participantsStarted 2026-03-01
Plain-language summary
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).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Expected survival time ≥ 6 months.
. No blood transfusion or treatment with hematopoietic stimulating factors within 14 days before screening, and meeting the following criteria:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events
Timeframe: From the screening period to 28 days after the last intraperitoneal perfusion treatment during the follow-up period
2
Incidence of serious adverse events
Timeframe: From the screening period to 28 days after the last intraperitoneal perfusion treatment during the follow-up period
3
Eastern Cooperative Oncology Group Performance status
Timeframe: From the screening period to 28 days after the last intraperitoneal perfusion treatment during the follow-up period
4
Surgical complications
Timeframe: From the screening period to 28 days after the last intraperitoneal perfusion treatment during the follow-up period
Timeframe: 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)
. Female subjects of childbearing potential or male subjects with partners of childbearing potential must use effective contraception throughout the treatment period and for 3 months after the last dose.
. Voluntary participation in the clinical study, with full understanding and signed informed consent form (ICF); willingness and ability to comply with all trial procedures.