Using heated chemotherapy during surgery for advanced stomach cancer
A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Locally Advanced Gastric Cancer
This study is testing if adding heated chemotherapy during surgery can help people with advanced stomach cancer live longer and have better outcomes compared to surgery alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Wuhan University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT04345770 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of hyperthermic intraperitoneal chemotherapy (HIPEC) combined with radical gastrectomy in patients with locally advanced gastric cancer. Participants are randomly assigned to either receive HIPEC after surgery or to undergo surgery alone. The study aims to determine if the addition of HIPEC improves overall survival rates compared to surgery without HIPEC. Patients will be monitored for five years post-treatment to assess outcomes related to cancer recurrence and survival.
Who should consider this trial
Good fit: Ideal candidates are individuals with histologically confirmed locally advanced gastric cancer who are eligible for radical gastrectomy and have no evidence of distant metastases.
Not a fit: Patients with distant metastases or peritoneal metastases, as well as those who have previously received chemotherapy or radiotherapy, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for patients with advanced gastric cancer.
How similar studies have performed: Other studies have shown promising results with HIPEC in various cancers, suggesting potential for success in this approach for gastric cancer as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histological proved diagnosis of locally advanced gastric cancer. * No evidence of distant metastases or peritoneal metastases. * Preoperative examination (CT/MRI) demonstrated resectable gastric cancer with T3-T4 stage. * Eligible for radical gastrectomy with D2 lymphadenectomy. * Have not received cytotoxic chemotherapy or radiotherapy. * Written informed consent is obtained prior to commencement of trial treatment. Exclusion Criteria: * Existence of distant metastasis or peritoneal metastasis during surgery (M1). * Any previous chemotherapy or radiotherapy * Active systemic infections * Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial. * Female patients who are pregnant or breast feeding
Where this trial is running
Wuhan, Hubei
- Wuhan University — Wuhan, Hubei, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.