Clinical trial · Interventional
Hyperthermic Intraperitoneal Chemotherapy for Advanced Gastric Cancer With Peritoneal Metastatis
A Randomized Controlled Clinical Trial of Hyperthermic Intraperitoneal Chemotherapy for Advanced Gastric Cancer With Peritoneal Metastatis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Exploratory Behavior | — | UNRESOLVED | — |
| Hyperthermic Intraperitoneal Chemotherapy | — | UNRESOLVED | — |
| Stage IV Gastric Cancer With Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperthermic Intraperitoneal Chemotherapy | Drug | Hyperthermic Intraperitoneal Chemotherapy | ALIAS |
| Without Hyperthermic Intraperitoneal Chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HIPEC and chemotherapy
- description
- Hyperthermic Intraperitoneal Chemotherapy and SOX（Tiggio+Oxaliplatin ）
- interventionNames
- Drug: Hyperthermic Intraperitoneal Chemotherapy
- type
- SHAM_COMPARATOR
- label
- Without HIPEC
- description
- Without Hyperthermic Intraperitoneal Chemotherapy，Only SOX（Tiggio+Oxaliplatin ）
- interventionNames
- Drug: Without Hyperthermic Intraperitoneal Chemotherapy
Primary outcomes (1)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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%。
References
Publications (1)
- DERIVEDLuo L, Zhang Z, Zeng H, Xu Y, Peng Y, Huang H, Lin Z, Xiong W, Wang W. Hyperthermic intraperitoneal chemotherapy plus SOX chemotherapy versus SOX chemotherapy alone in patients with gastric cancer and peritoneal metastasis: a phase II randomized clinical trial. J Gastrointest Oncol. 2025 Feb 28;16(1):17-26. doi: 10.21037/jgo-24-807. Epub 2025 Jan 9. PMID 40115934