Hyperthermic Intraperitoneal Chemotherapy for Advanced Gastric Cancer With Peritoneal Metastatis (NCT03604614) | Clinical Trial Compass
UnknownPhase 2
Hyperthermic Intraperitoneal Chemotherapy for Advanced Gastric Cancer With Peritoneal Metastatis
China56 participantsStarted 2017-06-01
Plain-language summary
The incidence rate of gastric cancer is high in Southeast Asia, so is the mortality rate.Due to the lack of specific performance, about 5%-20% of patients have found peritoneal metastases at the time of first diagnosis.At present, clinical studies on HIPEC in the treatment of patients with advanced gastric cancer peritoneal metastasis are almost related to abdominal perfusion after laparoscopic gastrectomy.Herein, we conduct a single-centre randomized controlled trial to explore the safety and feasibility of laparoscopic exploration combined with HIPEC in the treatment of advanced gastric cancer with peritoneal metastasis.
Who can participate
Age range
18 Years – 80 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:
* Primary gastric adenocarcinoma diagnosed pathologically by endoscopic biopsy；
* Laparoscopic exploration of patients with advanced gastric adenocarcinoma of peritoneal metastasis；
* Eastern Cooperative Oncology Group (ECOG): 0 ot 1；
* American Society of Anesthesiologists （ASA） score: I to Ⅲ；
* Patient informed consent。
Exclusion Criteria:
* Pregnancy or female in suckling period；
* Severe mental illness；
* Preoperative imaging or intraoperative exploration reveals distant blood, liver, lung, and brain metastases；
* 5 years of history of other malignant diseases；
* A history of unstable angina or myocardial infarction within 6 months；
* History of cerebral infarction or cerebral hemorrhage within 6 months；
* A history of sustained systemic corticosteroid treatment within 1 month；
* Emergency operation due to complication (bleeding, perforation or obstruction) caused by primary tumor；
* Pulmonary function test FEV1 \<predicted value 50%。
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
PFS
Timeframe: From date of randomization until the date of first documented progression or date of death for tumor cause, whichever came first, assessed 7 months
Trial details
NCT IDNCT03604614
SponsorGuangdong Provincial Hospital of Traditional Chinese Medicine