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The purpose of this study is to investigate the efficacy and safety of intraperitoneal and intravenous nab-paclitaxel plus Camrelizumab and S-1 conversion therapy for gastric cancer with positive exfoliative cancer cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Camrelizumab: 200mg,iv,30min, q3w, 4 cycles. Nab-Paclitaxel: intraperitoneal nab-paclitaxel 80 mg/m2 and intravenous nab-paclitaxel 180 mg/m2 on days 1, q3w, 4 cycles. 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, q3w, 4 cycles. For patients who were operable, the original regimen was continued for 4 cycles of adjuvant treatment after operation, followed by maintenance of carrelizumab monotherapy to 1 year. Inoperable patients were selected for follow-up treatment according to guidelines recommended by the investigator. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab Nab-Paclitaxel S-1 | Drug | Camrelizumab+S-1+Intraperitoneal nab-paclitaxel and intravenous nab-paclitaxel |
|
| 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 | 3years |
| Progression free survival (PFS) | Baseline to measured date of progression or death from any cause |
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Inclusion Criteria:
None previous chemotherapy, radiotherapy and other antitumor therapy;
Age:18 to 70 years old;
Man or female (except pregnant and lactating women);
Confirmed to gastric adenocarcinoma and HER2-negative;
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 certeria:
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 certeria:
ALT and AST≤2.5×ULN TBIL<1.5×ULN; Serum creatinine ≤1.5×ULN;
Left ventricular ejection fraction (LVEF) ≥50%;
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, Professor | Contact | 13930162111 | Zhaoqun516@126.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37841441 | Derived | Lv J, Wu J, Wu H, Ding P, Guo H, Yang P, Tian Y, Liu Y, Zhao Q. Study protocol of a phase II clinical trial evaluating the efficacy of neoadjuvant intraperitoneal and systemic albumin-bound paclitaxel combined with camrelizumab and S-1 in the treatment of patients with exfoliative cell-positive gastric cancer. Front Oncol. 2023 Sep 29;13:1201928. doi: 10.3389/fonc.2023.1201928. eCollection 2023. |
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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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| 3years |
| Objective response rate (ORR) | Baseline to measured stable disease | tumor assessment every 6 weeks since the treatment began,up to 3years |
| Disease control rate (DCR) | Baseline to measured progressive disease | tumor assessment every 6 weeks since the treatment began,up to 3years |
| Tumor regression grade (TRG) | TRG included four grades: Grade 0-3 | within 3 weeks after surgery |
| Adverse events | Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The number of Participants with adverse events will be recorded at each treatment visit. | 3 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |