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

• ClinicalTrials.gov Identifier: NCT03718624
• Recruitment Status: Unknown
• First Posted: October 24, 2018
• Last Update Posted: October 31, 2018
• Sponsor: Hebei Medical University
• Information provided by (Responsible Party): Qun Zhao, Hebei Medical University

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

Condition or disease	Intervention/treatment	Phase
Gastric Cancer With Positive Exfoliative Cancer Cells	Drug: apatinib; Drug: paclitaxel; Drug: S-1	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 36 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study of Intraperitoneal and Intravenous Paclitaxel Plus Apatinib and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells
• Estimated Study Start Date: October 30, 2018
• Estimated Primary Completion Date: October 30, 2019
• Estimated Study Completion Date: October 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. R0-resection rate [ Time Frame: within 3 weeks after surgery ]
   There was no residual by the microscope
2. Conversion to negative rate [ Time Frame: within 3 weeks after surgery ]
   Exfoliative cytology positive gastric cancer conversion to negative rate.

Secondary Outcome Measures :

1. Overall survival (OS) [ Time Frame: 5years ]
   Baseline to measured date of death from any cause
2. Progression free survival (PFS) [ Time Frame: 5years ]
   Baseline to measured date of progression or death from any cause
3. Adverse events [ Time Frame: 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.

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Qun Zhao; 13930162111; Zhaoqun516@126.com

Sponsors and Collaborators

Hebei Medical University

More Information

• Responsible Party: Qun Zhao, Principal Investigator, Hebei Medical University
• ClinicalTrials.gov Identifier: NCT03718624
• Other Study ID Numbers: HRA-G03
• First Posted: October 24, 2018
• Last Update Posted: October 31, 2018
• Last Verified: October 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Stomach Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Paclitaxel; Apatinib; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Protein Kinase Inhibitors; Enzyme Inhibitors