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

Phase 2

• Conditions: Gastric Cancer
• Interventions: Drug: paclitaxel apatinib S-1

• Registration Number: NCT03428425
• Lead Sponsor: Hebei Medical University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-02
• Study Start: 2018-02
• Study First Submitted: 2018-02-01
• Study First Submitted QC: 2018-02-05
• Last Update Submitted: 2018-02-05
• Study First Posted: 2018-02-09
• Last Update Posted: 2018-02-09
• Primary Completion: 2018-12
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• 1. Untreated (e.g. chemotherapy, radiotherapy and other antitumor therapy); 2. Age:18 to 70 years old; 3. Man or female (except pregnant and lactating women); 4. Confirmed to gastric adenocarcinoma; 5. 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; 6. Blood cell count has to meet the following certeria: WBC≥3.5×109/L; ANC≥1.5×109/L; PLT≥100×109/L; HB≥90g/L; 7. Liver/kidney function has to meet the following certeria: ALT and AST≤2.5×ULN TBIL<1.5×ULN； Serum creatinine ≤1.5×ULN; 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 9. Participants were willing to join in this study, good adherence and written informed consent.

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Exclusion Criteria

• 1. Patients with other malignant tumors within 5 years; 2. Metastasis was found to be visible to the naked eye; 3. 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); 4. History of psychiatric drugs abuse and can't quit or patients with mental disorders; 5. Patients with severe or uncontrollable mental illness; 6. 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; 7. Pregnant or lactating women; 8. It have serious harm to the patient's safety or affect the patients who have completed the research.

9. The researchers think inappropriate.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
apatinib paclitaxel S-1	paclitaxel apatinib S-1	-

Primary Outcome Measures

Name	Time	Method
R0-resection rate	within 3 weeks after surgery	There was no residual by the microscope
Conversion to negative rate	within 3 weeks after surgery	Exfoliative cytology positive gastric cancer conversion to negative rate

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	5years	Baseline to measured date of death from any cause
Progression free survival (PFS)	5years	Baseline to measured date of progression or death from any cause
Adverse events	5 years	Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.The number of Participants with adverse events will be recorded at each treatment visit