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

NCT03428425 | Unknown Phase 2

• 1 other identifier: HRA-G02
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate the efficacy and safety of HIPEC plus apatinib and S-1 in the conversion therapy of gastric cancer with positive exfoliative cancer cells

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Overall survival (OS)

  5years

• Progression free survival (PFS)

  5years

• Adverse events

  5 years

Study Arms (1)

apatinib paclitaxel S-1

EXPERIMENTAL

Drug: paclitaxel apatinib S-1

Interventions

paclitaxel apatinib S-1 DRUG

HIPEC: 43℃, 60min. the drug is paclitaxel : 70mg/m2 d1 d3 d5, The interval is not less than 24h , A total of three times. apatinib：500mg qd po, 28 days is a cycle.preoperative 2 cycles, 2 cycles after surgery. 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

apatinib paclitaxel S-1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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 certeria: 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 certeria: 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.

You may not qualify if:

• \- 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.
• \. The researchers think inappropriate.

Sponsors & Collaborators

• Hebei Medical University: lead

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Qun Zhao

CONTACT

13930162111; Zhaoqun516@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 9, 2018
• Study Start: February 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2024
• Last Updated: February 9, 2018

Record last verified: 2018-02