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Hyperthermic Intraperitoneal Chemotherapy for Advanced Gastric Cancer With Peritoneal Metastatis

NCT03604614 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2018-07-27

No results posted yet for this study

Summary

The incidence rate of gastric cancer is high in Southeast Asia, so is the mortality rate.Due to the lack of specific performance, about 5%-20% of patients have found peritoneal metastases at the time of first diagnosis.At present, clinical studies on HIPEC in the treatment of patients with advanced gastric cancer peritoneal metastasis are almost related to abdominal perfusion after laparoscopic gastrectomy.Herein, we conduct a single-centre randomized controlled trial to explore the safety and feasibility of laparoscopic exploration combined with HIPEC in the treatment of advanced gastric cancer with peritoneal metastasis.

Conditions

  • Stage IV Gastric Cancer With Metastasis
  • Hyperthermic Intraperitoneal Chemotherapy
  • Exploratory Behavior

Interventions

DRUG

Hyperthermic Intraperitoneal Chemotherapy

The investigators use Paclitaxel as peritoneal hyperthermic perfusion chemotherapy drugs，75mg/m2 for the first time，50mg/m2 for the second time and third time.The chemotherapy is SOX(Tiggio d1-d14 bid po and Oxaliplatin 130mg/m2 ivd d1 qd).The Tiggio dosage depends on the patient's body surface area, body surface area \<1.25m2 40mg/time, 1.25-1.50m2 50mg/time, \>1.50m2 60mg/time.

DRUG

Without Hyperthermic Intraperitoneal Chemotherapy

The chemotherapy is SOX(Tiggio d1-d14 bid po and Oxaliplatin 130mg/m2 ivd d1 qd).The Tiggio dosage depends on the patient's body surface area, body surface area \<1.25m2 40mg/time, 1.25-1.50m2 50mg/time, \>1.50m2 60mg/time.

Sponsors & Collaborators

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Wei Wang · Guangdong Provincial Hospital of Traditional Chinese Medicine

  • Wenjun Xiong · Guangdong Provincial Hospital of Traditional Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2017-08-24
Completion
2020-08-24

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03604614 on ClinicalTrials.gov