Clinical trial · Interventional
Efficacy of HIPEC in the Treatment of Locally Advanced Gastric Cancer After radIcal Gastrectomy With D2
A Phase III Study of Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Gastric Cancer After radIcal Gastrectomy With D2
- 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)
HIPEC-01 is a prospective, open, randomized multicenter phase III clinical study conducted in China. To determine the efficacy of hyperthermic intraperitoneal chemotherapy (HIPEC) in the treatment of locally advanced gastric cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and postoperative chemotherapy. Patients in the control group just undergo radical gastrectomy with D2 lymphadenectomy followed by postoperative chemotherapy. Patients in both groups receive 6-8 cycles of postoperative systemic chemotherapy (XELOX or SOX regimens) and are followed up for 5 years or until death.
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| D2 lymphadenectomy | Procedure | — | UNRESOLVED |
| Hyperthermic Intraperitoneal Chemotherapy | Procedure | — | UNRESOLVED |
| Systemic chemotherapy (XELOX or SOX regimens) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HIPEC group
- description
- Postoperative hyperthermic intraperitoneal chemotherapy (HIPEC) is performed after radical surgery, followed by 6-8 cycles of systemic chemotherapy. The first HIPEC is conducted within 48 h after surgery: Paclitaxel 75 mg/m\^2, 43°C, 60min. The second HIPEC is performed after 24 hours of the first HIPEC. The regimens are Paclitaxel 100 mg/m\^2, 43°C, 60min. Systemic chemotherapy (XELOX or SOX regimens): XELOX regimen: Oxaliplatin: 130 mg/m\^2, IV, d1; Capecitabine: 1 g/m\^2 bid, days 1-14, every 3 weeks for a total of 6-8 cycles. If XELOX regimen is not conducted in some collaborators, SOX regimen is also permitted. The regimen is Oxaliplatin: 130 mg/m\^2, IV, d1; S-1, 40-60 mg/m\^2 bid, po, day 1-14, every 3 weeks for a total of 6-8 cycles.
- interventionNames
- Procedure: D2 lymphadenectomy
- Procedure: Hyperthermic Intraperitoneal Chemotherapy
- Drug: Systemic chemotherapy (XELOX or SOX regimens)
- type
- PLACEBO_COMPARATOR
- label
- Control group
- description
- 6-8 cycles of systemic chemotherapy (XELOX or SOX regimens) were performed after radical gastrectomy with D2 lymphadenectomy. XELOX regimen is Oxaliplatin: 130 mg/m\^2, IV, d1; Capecitabine: 1 g/m\^2 bid, days 1-14, every 3 weeks for a total of 6-8 cycles. If XELOX regimen is not conducted in some collaborators, SOX regimen as comment systemic chemotherapy in Asia is also permitted to treat the patients. The treatment bundles are listed as follows: Oxaliplatin: 130 mg/m\^2, IV, d1; S-1, 40-60 mg/m\^2 bid (S-1: BSA \<1.25m\^2, 40mg bid, 1.25m\^2≤ BSA ≤1.5m\^2, 50mg bid, BSA\>1.5m\^2, 60 mg bid), po, day 1-14, every 3 weeks for a total of 6-8 cycles.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 18 \< age ≤ 70 years old * Male or Non pregnant female * The Eastern Cooperative Oncology Group (ECOG) status 0-1 * T3 or T4 gastric adenocarcinoma (visual determination according to AJCC 2010 7th edition) * No distance metastasis, eligible for D2 lymphadenectomy * 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: * Have other cancer within 5 years * Existence of distance metastasis during surgey (M1) * 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% * Epileptic seizures patients need medicine control * Uncontroled mental disease or mental disorder * Drug abuse or psychological or social factors affect the judgment of results * Contraindication to any therapy contained in this regimen specific to the study * Receiving other chemotherapy, radiotherapy or immunotherapy * Without given written informed consent
References
Publications (0)
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