Clinical trial · Interventional
Efficacy of HIPEC in the Treatment of Patients With Locally Advanced Gastric Cancer
A Phase III Study of Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Gastric Cancer After radIcal Gastrectomy With D2 Lymphadenectomy
NCT02240524CI-TRIAL-00015618HIPECunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of this study is to study the efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of patients with locally advanced gastric cancer after radical gastrectomy with D2 lymphadenectomy. It is a multicentric and randomised phase III trial.
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 |
|---|---|---|---|
| Advanced Gastric Adenocarcinoma | Gastric Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| D2 lymphadenectomy | Procedure | — | UNRESOLVED |
| HIPEC | Procedure | — | UNRESOLVED |
| Systemic chemotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- D2 lymphadenectomy and HIPEC and Systemic chemotherapy
- description
- Intraoperative and postoperative hyperthermic intraperitoneal chemotherapy (twice HIPEC) were performed after radical gastrectomy with D2 lymphadenectomy, followed by 8 cycles of systemic chemotherapy. HIPEC was conducted within 48 h after surgery: Normal saline 3000ml-4000ml, Paclitaxel 75mg/m\^2, 43°C, 60min. Systemic chemotherapy (XELOX): Oxaliplatin: 130mg/m\^2, d1, Intravenous infusion, every 3 weeks. Capecitabine: 1g/m\^2 bid, days 1-14, every 3 weeks and maximum 8 cycles, or progression/intolerance.
- interventionNames
- Procedure: D2 lymphadenectomy
- Procedure: Systemic chemotherapy
- Procedure: HIPEC
- type
- PLACEBO_COMPARATOR
- label
- D2 lymphadenectomy+Systemic chemotherapy
- description
- 8 cycles of systemic chemotherapy were performed after radical gastrectomy with D2 lymphadenectomy. Systemic chemotherapy (XELOX): Oxaliplatin: 130mg/m\^2, d1, Intravenous infusion, every 3 weeks. Capecitabine: 1g/m\^2 bid, days 1-14, every 3 weeks and maximum 8 cycles, or progression/intolerance.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 18 \< age ≤ 65 years old * Male or Non pregnant female * The Eastern Cooperative Oncology Group (ECOG) status ≤ 2 * Histologically diagnosed as T4 gastric adenocarcinoma (determined from data obtained by endoscopic ultrasound or CT scan) * Have not received cytotoxic chemotherapy, radiotherapy or immunotherapy * White blood cells \> 4,000/mm3 * neutrophils ≥ 1,500/mm3 * platelets ≥ 100,000/mm3 * hemoglobin\>9g/l * Alanine transaminase (ALT) and aspartate aminotransferase (AST) \< or = 2.5 times upper limit of nominal (ULN) * total bilirubin (TBIL) \< 1.5 times ULN * serum creatinine \< 1 times ULN * Having given written informed consent prior to any procedure related to the study Exclusion Criteria: * Existence of macroscopic peritoneal implants * Prior malignant tumors with detectable signs of recurrence or distant metastasis * Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction\<50% * Receiving other cytotoxic chemotherapy * High grade of intra-abdominal adhesions * Contraindication to any therapy contained in this regimen specific to the study Without given written informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.