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

Primary Purpose

Gastric Cancer With Positive Exfoliative Cancer Cells

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

apatinib

paclitaxel

S-1

About this trial

This is an interventional treatment trial for Gastric Cancer With Positive Exfoliative Cancer Cells

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

paclitaxel,apatinib and S-1

Arm Description

Outcomes

Primary Outcome Measures

R0-resection rate

There was no residual by the microscope

Conversion to negative rate

Exfoliative cytology positive gastric cancer conversion to negative rate.

Secondary Outcome Measures

Overall survival (OS)

Baseline to measured date of death from any cause

Progression free survival (PFS)

Baseline to measured date of progression or death from any cause

Adverse events

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.

Full Information

NCT ID

NCT03718624

First Posted

October 23, 2018

Last Updated

October 29, 2018

Sponsor

Hebei Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03718624

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

October 30, 2018 (Anticipated)

Primary Completion Date

October 30, 2019 (Anticipated)

Study Completion Date

October 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hebei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer With Positive Exfoliative Cancer Cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

paclitaxel,apatinib and S-1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

apatinib

Intervention Description

apatinib：500mg qd po, 28 days is a cycle. preoperative 2 cycles, 2 cycles after surgery.

Intervention Type

Drug

Intervention Name(s)

paclitaxel

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

S-1

Intervention Description

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.

Primary Outcome Measure Information:

Title

R0-resection rate

Description

There was no residual by the microscope

Time Frame

within 3 weeks after surgery

Title

Conversion to negative rate

Description

Exfoliative cytology positive gastric cancer conversion to negative rate.

Time Frame

within 3 weeks after surgery

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Description

Baseline to measured date of death from any cause

Time Frame

5years

Title

Progression free survival (PFS)

Description

Baseline to measured date of progression or death from any cause

Time Frame

5years

Title

Adverse events

Description

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.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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; 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Qun Zhao

Phone

13930162111

Zhaoqun516@126.com

12. IPD Sharing Statement

Learn more about this trial

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

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