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

Hebei Medical University0 sites36 target enrollmentOctober 30, 2018

ConditionsGastric Cancer With Positive Exfoliative Cancer Cells

Interventionsapatinib paclitaxel S-1

Drugsapatinib paclitaxel S-1

Overview

Phase: Phase 2
Intervention: apatinib
Conditions: Gastric Cancer With Positive Exfoliative Cancer Cells
Sponsor: Hebei Medical University
Enrollment: 36
Primary Endpoint: R0-resection rate
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

October 30, 2018

End Date

October 30, 2020

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hebei Medical University

Responsible Party

Principal Investigator

Qun Zhao

Principal Investigator

Hebei Medical University

Eligibility Criteria

Inclusion Criteria

•Untreated (e.g. chemotherapy, radiotherapy and other antitumor therapy);
•Age:18 to 70 years old;
•Man or female (except pregnant and lactating women);
•Confirmed to gastric adenocarcinoma;
•Proven gastric cancer of T stage was T3 and T4, and no distant metastasis was observed. The exfoliative cancer cells detection in peritoneal washes was positive;
•Blood cell count has to meet the following criteria:
•WBC≥3.5×109/L; ANC≥1.5×109/L; PLT≥100×109/L; HB≥90g/L;
•Liver/kidney function has to meet the following criteria:
•ALT and AST≤2.5\*ULN TBIL\<1.5\*ULN； Serum creatinine ≤1.5\*ULN;
•Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;

Exclusion Criteria

•Patients with other malignant tumors within 5 years;
•Metastasis was found to be visible to the naked eye;
•It has serious or uncontrolled heart diseases and infections (Including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, poor-controlled hypertension and so on);
•History of psychiatric drugs abuse and can't quit or patients with mental disorders;
•Patients with severe or uncontrollable mental illness;
•Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +).Has melena and hematemesis in two months;
•Pregnant or lactating women;
•It have serious harm to the patient's safety or affect the patients who have completed the research.
•The researchers think inappropriate.