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

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

Study Overview

• Status: Unknown
• Conditions: Gastric Cancer With Positive Exfoliative Cancer Cells
• Intervention / Treatment: Drug: apatinib; Drug: paclitaxel; Drug: S-1

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 2

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: paclitaxel,apatinib and S-1

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R0-resection rate	There was no residual by the microscope	within 3 weeks after surgery
Conversion to negative rate	Exfoliative cytology positive gastric cancer conversion to negative rate.	within 3 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	Baseline to measured date of death from any cause	5years
Progression free survival (PFS)	Baseline to measured date of progression or death from any cause	5years
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

Collaborators and Investigators

• Sponsor: Hebei Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 30, 2018
• Primary Completion (Anticipated): October 30, 2019
• Study Completion (Anticipated): October 30, 2020

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (Actual): October 24, 2018

Study Record Updates

• Last Update Posted (Actual): October 31, 2018
• Last Update Submitted That Met QC Criteria: October 29, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Protein Kinase Inhibitors; Paclitaxel; Apatinib
• Other Study ID Numbers: HRA-G03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No