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| Name | Class |
|---|---|
| CSPC Ouyi Pharmaceutical Co., Ltd. | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of irinotecan liposome injection in combined with oxaliplatin plus tegafur (NASOX) for postoperative adjuvant chemotherapy for pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irinotecan liposome injection+ Oxaliplatin +Tegafur | Experimental | Oxaliplatin: 60mg/m2, d1, ivgtt, 2h; Repeat every 15 days; Irinotecan liposomes: 50mg/m2, d1, ivgtt, 90min; Repeat every 15 days; Tegafur: 40-60mg, BID, po, d1-d10, repeat every 15 days; 30 days as one cycle, 6 treatment cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan liposome injection | Drug | Postoperative adjuvant therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival, DFS | the time from the start of randomization (or the start of treatment in a one-arm trial) to the recurrence of disease or death from any cause, whichever occurs first. | baseline up to approximately 21.6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (aes) were determined and graded according to NCI-CTCAE version 5.0, and evaluated by the overall incidence of AE, the incidence of AE grade 3 or above, and the incidence of SAE | Hematologic and non-hematologic adverse events during adjuvant therapy (according to NCI-CTCAE5.0); | baseline up to approximately 7 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| KuiRong Jiang, archiater | Contact | 15312995688 | Jiangkuirong@163.com |
| Name | Affiliation | Role |
|---|---|---|
| KuiRong Jiang, archiater | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FirstNanjingMU | Recruiting | Nanjing | Jiangsu | 025 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C584112 | irinotecan sucrosofate |
| D000077150 | Oxaliplatin |
| D005641 | Tegafur |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005472 | Fluorouracil |
| D014498 | Uracil |
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| Overall Survival, OS |
the time from the start of randomization (or the start of treatment in a one-arm trial) to death from any cause. |
| baseline up to approximately55 months. |
| Quality of life, QOL | It reflects the ability of human activities to improve the survival level and survival chances, evaluated according to EORTC Quality of life measurement scale QLQ-C30 V3.0 assessment. | baseline up to approximately 55 months. |
| The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy | The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy | baseline up to approximately 7 months. |
| he results were presented in terms of the proportion of patients who were replaced with 5-FU/LV due to Tegafur intolerance | The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy and the proportion of patients who were replaced with 5-FU/LV due to Tegafur intolerance | baseline up to approximately 7 months. |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011744 |
| Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |