Gastric Cancer
Conditions
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
Interventions
DRUGpaclitaxel apatinib S-1
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
Sponsors
Hebei Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| R0-resection rate | within 3 weeks after surgery | There was no residual by the microscope |
| Conversion to negative rate | within 3 weeks after surgery | Exfoliative cytology positive gastric cancer conversion to negative rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 5years | Baseline to measured date of death from any cause |
| Progression free survival (PFS) | 5years | Baseline to measured date of progression or death from any cause |
| Adverse events | 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 |
Contacts
Primary ContactQun Zhao
Outcome results
None listed