S-1 Combined Cisplatin HIPEC for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis
NCT ID: NCT02291211
Last Updated: 2014-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2014-09-30
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
S-1 plus cisplatin HIPEC
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.
S-1 plus cisplatin HIPEC
Using cisplatin in HIPEC plus oral S-1
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
S-1 plus cisplatin HIPEC
Using cisplatin in HIPEC plus oral S-1
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tang-Du Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Helong Zhang, Professor
Role: PRINCIPAL_INVESTIGATOR
Tang-Du Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
IEC of Insititution for National Drug Clinical Trials,Tangdu Hospital,Fourth Military Medical University
Xi'an, Shaanxi, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TDCCC006
Identifier Type: -
Identifier Source: org_study_id