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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paclitaxel,apatinib and S-1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| apatinib | Drug | apatinib:500mg qd po, 28 days is a cycle. preoperative 2 cycles, 2 cycles after surgery. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Untreated (e.g. chemotherapy, radiotherapy and other antitumor therapy);
Age:18 to 70 years old;
Man or female (except pregnant and lactating women);
Confirmed to gastric adenocarcinoma;
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;
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;
Liver/kidney function has to meet the following criteria:
ALT and AST≤2.5*ULN TBIL<1.5*ULN; Serum creatinine ≤1.5*ULN;
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
Participants were willing to join in this study, good adherence and written informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qun Zhao | Contact | 13930162111 | Zhaoqun516@126.com |
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| paclitaxel | 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 | 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. |
|
| 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 |
| ID | Term |
|---|---|
| C553458 | apatinib |
| D017239 | Paclitaxel |
| C079198 | S 1 (combination) |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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