Clinical trial · Interventional
SP Intravenous Chemotherapy Versus SP by HIPEC in Stage Ⅲ Patients After D2 Gastrectomy
S-1 With Cisplatin Intravenous Chemotherapy Versus S-1 Plus Cisplatin Hyperthermic Intraperitoneal Chemotherapy in Stage Ⅲ Patients After D2 Gastrectomy：a Randomized Controlled Study
NCT02396498CI-TRIAL-00017217unknownPhase 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 study is designed to assess the safety and efficacy of S-1 plus cisplatin hyperthermic intraperitoneal chemotherapy in stage Ⅲ patients after D2 gastrectomy
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 |
|---|---|---|---|
| Stage Ⅲ Gastric Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HIPEC | Drug | Hyperthermic Intraperitoneal Chemotherapy | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- D2 radical gastrectomy+Systemic chemotherapy
- description
- 8 cycles of systemic chemotherapy were performed for stage Ⅲ patients after D2 gastrectomy .Systemic chemotherapy(SP): Cisplatin: 60mg/m\^2, d1 , Intravenous infusion, every 3 weeks. S-1: 40-60mg/m\^2 bid, days 1-14, every 3 weeks .Subjects should be given maximum 8 cycles, or progression/intolerance.
- type
- EXPERIMENTAL
- label
- D2 radical gastrectomy+HIPEC
- description
- 8 cycles of hyperthermic intraperitoneal chemotherapy (cisplatin) and S-1(oral) were performed after D2 radical gastrectomy. HIPEC was conducted in d1 and d3: Normal saline 2000ml-5000ml, Cisplatin 60mg/m\^2, 43°C, 60min. every 3 weeks. S-1: 40-60mg/m\^2 bid, days 1-14, every 3 weeks.Subjects should be given maximum 8 cycles, or progression/intolerance.
- interventionNames
- Drug: HIPEC
Primary outcomes (1)
- measure
- DFS: Disease-Free Survival
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 * Histologically diagnosed as stageⅢ gastric adenocarcinoma，and perform D2 radical gastrectomy，as well as have not received any Anti-tumor therapy：chemotherapy,biological treatment or molecular targeted therapy , etc. * The Eastern Cooperative Oncology Group (ECOG) status ≤ 2 * Having given written informed consent prior to any procedure related to the study * Expected survival time ≥3 months Exclusion Criteria: * History of severe hypersensitivity reactions to the ingredients of S-1 or Cisplatin * Hemoglobin\<90g/L * Inadequate hematopoietic function which is defined as below: * white blood cell (WBC) less than 3,500/mm\^3 * absolute neutrophil count (ANC) less than 1,500/mm\^3 * platelets less than 80,000/mm\^3 * Inadequate hepatic or renal function which is defined as below: * serum bilirubin greater than 2 times the upper limit of normal range * alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN if no demonstrable liver metastases or greater than 5 times the ULN in the presence of liver metastases * blood creatinine level greater than 1.5 times ULN,Creatinine clearance\<60ml/min * Receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug * Women who is pregnant or lactating or fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period (Including male) * Psychiatric disorder or symptom that makes participation of the patient difficult * Myocardial infarction, existing serious or unstable angina, and patients with cardiac insufficiency in 6 months * Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis or pulmonary fibrosis, glomerulonephritis ,renal failure, poorly-controlled diabetes * Known DPD deficiency * Participate in other clinical trial before the start of this trial * Patient compliance is bad or researchers believe that patients are not suitable for this treatment * Known to have active hepatitis patients
References
Publications (1)
- DERIVEDLiu L, Sun L, Zhang N, Liao CG, Su H, Min J, Song Y, Yang X, Huang X, Chen D, Chen Y, Zhang HW, Zhang H. A novel method of bedside hyperthermic intraperitoneal chemotherapy as adjuvant therapy for stage-III gastric cancer. Int J Hyperthermia. 2022;39(1):239-245. doi: 10.1080/02656736.2022.2028018. PMID 35100917