A Study of Intraperitoneal and Intravenous Paclitaxel Plus Apatinib and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells

Sponsor
Hebei Medical University
Study ID
NCT03718624
Phase
PHASE2
Status
Unknown

Conditions

  • Gastric Cancer With Positive Exfoliative Cancer Cells

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • apatinib — DRUG
    apatinib：500mg qd po, 28 days is a cycle. preoperative 2 cycles, 2 cycles after surgery.
  • paclitaxel — DRUG
    Paclitaxel: intraperitoneal paclitaxel 20 mg/m2 and intravenous paclitaxel 50 mg/m2 on days 1 and 8 ，21 days is a cycle. preoperative 3 cycles, 3 cycles after surgery.
  • S-1 — DRUG
    S-1： According to the body surface area, BSA \<1.25m2，40mg bid; 1.25m2≤BSA≤1.5m2，50mg bid; BSA \>1.5m2, 60mg bid. Take the medicine twice daily for 2 weeks, then suspend for 1 week. preoperative 3 cycles, 3 cycles after surgery.

Study Details

The purpose of this study is to investigate the efficacy and safety of intraperitoneal and intravenous paclitaxel plus apatinib and S-1 in the conversion therapy of gastric cancer with positive exfoliative cancer cells

Key Dates

Start date
Oct 30, 2018
Status verified
Oct 2018
Primary completion
Oct 30, 2019
Completion
Oct 30, 2020

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: paclitaxel,apatinib and S-1

Primary Outcome Measure

R0-resection rate [ Time Frame: within 3 weeks after surgery ]

Central Contacts