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

NCT ID: NCT03718624

Last Updated: 2018-10-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-30
• Study Completion Date: 2020-10-30

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

Conditions

Gastric Cancer With Positive Exfoliative Cancer Cells

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

paclitaxel,apatinib and S-1

Group Type: EXPERIMENTAL

apatinib

Intervention Type: DRUG

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

paclitaxel

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Interventions

apatinib

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

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Qun Zhao

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Qun Zhao

Role: CONTACT

Phone: 13930162111

Email: Zhaoqun516@126.com

Other Identifiers

HRA-G03

Identifier Type: -

Identifier Source: org_study_id