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

H

Hebei Medical University

Status and phase

Unknown
Phase 2

Conditions

Gastric Cancer With Positive Exfoliative Cancer Cells

Treatments

Drug: S-1
Drug: apatinib
Drug: paclitaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT03718624
HRA-G03

Details and patient eligibility

About

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

Enrollment

36 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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;
  • Participants were willing to join in this study, good adherence and written informed consent.

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.

Trial design

36 participants in 1 patient group

paclitaxel,apatinib and S-1
Experimental group
Treatment:
Drug: paclitaxel
Drug: apatinib
Drug: S-1

Trial contacts and locations

0

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Central trial contact

Qun Zhao

Data sourced from clinicaltrials.gov

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