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Status unknownNCT02396498Updated Mar 24, 2015

SP Intravenous Chemotherapy Versus SP by HIPEC in Stage Ⅲ Patients After D2 Gastrectomy

A Phase 3 interventional study of HIPEC in Stage Ⅲ Gastric Cancer, sponsored by Tang-Du Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-03-24.

Sponsored by Tang-Du Hospital · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
270
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

Read the detailed description

The study is a randomized clinical trial，and subjects wuill be assigned two arms: SP Intravenous Chemotherapy or SP by HIPEC .After 8 cycles treatment,we assess the safety and efficacy.

02

Conditions studied

  • Stage Ⅲ Gastric Cancer
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In context

Lead sponsor

Tang-Du Hospital is the lead sponsor of 166 studies on the registry; 77 are open to participants now.

Browse Tang-Du Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
270 participants (estimated)

Study arms

  • Placebo comparator
    D2 radical gastrectomy+Systemic chemotherapy

    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.

  • Experimental
    D2 radical gastrectomy+HIPEC

    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.

    Drug: HIPEC

Interventions

  • DrugHIPEC

    Using cisplatin in HIPEC plus oral S-1

    Also known as: hyperthermic intraperitoneal chemoperfusion

06

What researchers measure

Primary outcomes

  1. DFS: Disease-Free Survival

    from the date of random to the date of recurrence or death for disease progression.

    Time frame: 2 years

Secondary outcomes

  1. OS: Overall Survival

    From the date of random to the date of death or to the end of follow-up

    Time frame: 5 years

  2. The quality of life

    The subjects should finish the quality of life scale by themselves before treament in every cycle.

    Time frame: 6 months

  3. Safety as measured by Adverse Events and Serious Adverse events In the process of the total treatment according CTCAE4.0

    record and collect subjects' AE and SAE In the process of the total treatment according CTCAE4.0

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • IEC of Insititution for National Drug Clinical Trials,Tangdu Hospital,Fourth Military Medical University
    Xi'an, Shaanxi 029, China
    Recruiting
08

References and documents

Publications

  • Liu 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. PubMed 35100917 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02396498
Lead sponsor
Tang-Du Hospital
Responsible party
Sponsor
First posted
Mar 24, 2015
Start date
Apr 2014
Primary completion
Apr 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Mar 24, 2015

Study contacts

Helong Zhang, Professor
Contact
cnxazhl@163.com
029-87777225
Helong Zhang, Professor
principal investigator · Tang-Du Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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