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

Gastric Cancer With Positive Exfoliative Cancer Cells Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03718624
• Other study ID #: HRA-G03
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 30, 2018
• Est. completion date: October 30, 2020

Study information

• Verified date: October 2018
• Source: Hebei Medical University
• Contact: Qun Zhao
• Phone: 13930162111
• Email: Zhaoqun516[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 criteria:

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 criteria:

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.

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.

Related Conditions & MeSH terms

• Gastric Cancer With Positive Exfoliative Cancer Cells
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R0-resection rate	There was no residual by the microscope	within 3 weeks after surgery
Primary	Conversion to negative rate	Exfoliative cytology positive gastric cancer conversion to negative rate.	within 3 weeks after surgery
Secondary	Overall survival (OS)	Baseline to measured date of death from any cause	5years
Secondary	Progression free survival (PFS)	Baseline to measured date of progression or death from any cause	5years
Secondary	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.	5 years