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The aim of this study was to compare the efficacy and safety of intravenous or intraperitoneal paclitaxel plus FOLFOX as first-line treatment in AGC with peritoneal metastases, a phase II Clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POF | Experimental | The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days. The combined chemotheraphy will be treated for 9 circle. then,the capetabine was allowed |
|
| FOLFOX plus PAC(ip) | Experimental | The regimen consisted of oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2) plus paclitaxel (80 mg/m2) intra-peritoneally.Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POF | Drug | Paclitaxel plus Oxaliplatin plus Leucovorin plus 5-FU |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival(OS) | The length of time from enrollment until the time of death | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event(AE) | Adverse Event according to NCI CTCAE 5 criteria | 6month |
| Objective Overall Response Rate (ORR) | Clinical response of treatment according to RESIST v1.1 criteria |
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Inclusion Criteria:
Exclusion Criteria:
- Patients who have received previous chemotherapy for the treatment of metastatic or unresectable gastric or GEJ adenocarcinoma are ineligible.
unstable angina, New York Heart Association (NYHA) grade II or greater, congestive heart failure, history of myocardial infarction within 6 months Evidence of bleeding diathesis or coagulopathy.
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C410216 | Folfox protocol |
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| FOLFOX plus PAC(ip) |
| Drug |
FOLFOX plus intraperitoneally paclitaxel |
|
| 6month |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |