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The purpose of the prospective, open, randomized controlled, multicenter, exploratory clinical study is to evaluate efficacy and safety of NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX for Conversion Therapy for Locally Advanced Pancreatic Cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NALIRINOX combined with PD-1 synchronous sequential SBRT group | Experimental | Nal-IRI+Oxaliplatin+5- FU +PD-1, these drugs are given on d1, d15, 28 days as one cycle, SBRT is performed during the third and fourth cycle. |
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| NALIRIFOX group | Experimental | Nal-IRI+Oxaliplatin+5- FU, these drugs are given on d1, d15, 28 days as one cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nal-lRl+Oxaliplain+5- FU +PD 1 | Drug | Nal-lRl+Oxaliplatin+5- FU +PD-1, these drugs are given on d1, d15, 28 days as one cycle, SBRT is performed during the third and fourth cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| 1 year OS rate | Proportion of patients alive from randomization to 1 year | Up to 12 months] |
| Measure | Description | Time Frame |
|---|---|---|
| R0/R1 rate | Percentage of patients who achieved R0/RI resection | Up to 6 months |
| The rate of mPR | Proportion of patients who achieved mPR by post-operative specimen testing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiu Yudong M.D., Ph.D | Contact | +86-025-83106666 | yudongqiu510@163.com |
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| Nal-lRl+Oxaliplain+5- FU | Drug | Nal-lRl+Oxaliplatin+5- FU, these drugs are given on d1, d15, 28 days as one cycle. |
|
| Up to 6 months |
| OS | Time from randomization to death | Up to 24 months |
| ORR | According to RECIST version 1.1, the proportion of patients who achieved remission (PR+CR) after treatment and maintained the minimum time-frame requirement. | Up to 6 months |
| PFS | Time from randomization to disease progression and/or death. | Up to 12 months |
| Surgical resection rate | Operable rate | Up to 6 months |
| The incidence of grade 3 or higher AE and serious adverse event(SAE) [Safety] | Using the Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, we analyzed the data of all subjects who received at least one study treatment. We collected and summarized the overall incidence of adverse events (AE), the incidence of grade 3 or higher AE, and the incidence of serious adverse events (SAE). | From the first treatment to 28 days after the last treatment, about 6 months |