Clinical trial · Interventional
S-1 Combined Cisplatin HIPEC for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis
Phase Ⅱ Study of S-1 Combined Cisplatin Hyperthermic Intraperitoneal Chemotherapy for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis
NCT02291211CI-TRIAL-00016072unknownPhase 2ClinicalTrials.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)
This study is designed to investigate the efficacy of S-1 plus cisplatin hyperthermic intraperitoneal chemotherapy for advanced gastric patients of gastric cytoreductive surgery (CRS)
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 IV Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S-1 plus cisplatin HIPEC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- S-1 plus cisplatin HIPEC
- description
- 8 cycles of hyperthermic intraperitoneal chemotherapy (cisplatin) and S-1(oral) were performed after palliative operation gastric cancer of stage IV limited peritoneal metastasis. 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: S-1 plus cisplatin HIPEC
Primary outcomes (1)
- measure
- PFS: Progression Free Survival
- timeFrame
- 2 years
- description
- from randomization to disease progression or death
Secondary outcomes (2)
- measure
- OS: Overall 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 * Patients with histologically confirmed gastric cancer (adenocarcinoma), stage IV (limited to the abdominal cavity), accpeted palliative cytoreductive surgery and no prior chemotherapy, biological therapy or targeted anti-cancer 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: * Known to have abdominal viscera metastasis of gastric cancer patients * 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 * Have the history of allograft transplantation * Conducted the autologous bone marrow transplantation in 4 weeks * Participate in other clinical trial before the start of this trial in 4 weeks * Patient compliance is bad or researchers believe that patients are not suitable for this treatment * Known to have active hepatitis patients * HER-2-positive patients (ICH3+or FISH+) * History of severe hypersensitivity reactions to the ingredients of S-1 or Cisplatin
References
Publications (0)
Data not yet available
No reference posted for this study.