Clinical trial · Interventional
Radical Gastrectomy With/Without HIPEC in Advanced Gastric Cancer Patients
Prospective Phase III Trial Using Radical Gastrectomy With/Without HIPEC in Advanced Gastric Cancer Patients Including Adenocarcinoma of the Esophagogastric Junction
- 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)
Patients with histological proven advanced gastric cancer (including cancer of the esophagogastric junction (AEG) without evidence of distant metastases, who fulfill the inclusion and exclusion criteria, can be recruited in this study. There are two treatment groups (A and B). The D2 radical gastrectomy will be applied in both groups. Patients randomized into group B will be treated with an intraperitoneal (in the abdominal cavity) chemoperfusion with cisplatin(75mg/m2 max 150mg/m2 max 5L ). Patients randomized into group A will not accept intraperitoneal chemoperfusion. Patients in both groups receive 6 cycles of postoperative chemotherapy (SOX or XELOX) within 4-12 weeks after the surgical procedure and are followed up for 24 months.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm of Stomach | Malignant Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intraperitoneal chemoperfusion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- without HIPEC
- description
- Patients will be treated with a D2 radical gastrectomy for advanced gastric cancer and postoperative chemotherapy (SOX or XELOX).
- type
- EXPERIMENTAL
- label
- with HIPEC
- description
- Patients will be treated with a D2 radical gastrectomy for advanced gastric cancer and intraperitoneal chemoperfusion with cisplatin and postoperative chemotherapy as described for the control group. Cisplatin: 75mg/m2 (max 150mg/m2 max 5L )
- interventionNames
- Procedure: intraperitoneal chemoperfusion
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histological proved diagnosis of peritoneal metastasized gastric cancer including carcinoma of the AEG. * No evidence of distant metastases * preoperative examination (CT/MRI) demonstrated resectable gastricc cancer with T3-T4 stage * Written informed consent is obtained prior to commencement of trial treatment Exclusion Criteria: * Any previous chemotherapy or radiotherapy, and any investigational treatment for gastric cancer * Active systemic infections * Patients with known interstitial lung disease with New York Heart Association classification \> 2 * Serious cardiac dysrhythmia or condition, New York Heart Association classification of III or IV, congestive cardiac failure * cardiac arrhythmia * Inadequate renal function at the beginning of the trial, defined as GFR less than \<60 ml/min * Inadequate liver function at the beginning of the trial, defined as Bilirubin \>1.5 times ULN * Inadequate bone marrow function at the beginning of the trial, defined as platelet count less than \<150 GPT/L or neutrophil granulocyte count less than \<1.5 GPT/ * Active vaccination within 6 weeks prior to randomisation * Active hepatitis B or C infection * Female patients who are pregnant or breast feeding * Missing of capacity to contract * contraindication to the drugs which are used in the trial * Participation in another therapeutic clinical trial
References
Publications (0)
Data not yet available