S-1 Combined Cisplatin HIPEC for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis

Phase 2

• Conditions: Stage IV Gastric Cancer
• Interventions: Drug: S-1 plus cisplatin HIPEC

• Registration Number: NCT02291211
• Lead Sponsor: Tang-Du Hospital

Brief Summary

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)

Detailed Description

This project is a single-center, open clinical observation the safety and efficacy that stage IV limited peritoneal metastasis of gastric cancer patients accept S-1 plus hyperthermic intraperitoneal chemotherapy . With advanced gastric patients of confined to the peritoneal after CRS as the research object, with progression-free survival and overall survival, adverse events as the end points.

Study Timeline

• Status Verified: 2014-09
• Study Start: 2014-09
• Study First Submitted: 2014-11-11
• Study First Submitted QC: 2014-11-13
• Last Update Submitted: 2014-11-13
• Study First Posted: 2014-11-14
• Last Update Posted: 2014-11-14
• Primary Completion: 2016-10
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
S-1 plus cisplatin HIPEC	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.

Primary Outcome Measures

Name	Time	Method
PFS: Progression Free Survival	2 years	from randomization to disease progression or death

Secondary Outcome Measures

Name	Time	Method
OS: Overall Survival	5 years	from randomization to death from any cause
Safety as measured by recording the subjects' Adverse Events from randomization to termination	2 years	Record the subjects' AEs from randomization to termination

Trial Locations

Locations (1)

IEC of Insititution for National Drug Clinical Trials,Tangdu Hospital,Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China