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To explore the efficacy and safety of surufatinib in combination with AG regimen verus AG regimen as peri-operative treatment in high - risk resectable or borderline resectable pancreatic cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SUR+AG | Experimental | Surufatinib Plus Gemcitabine and Nab-paclitaxel |
|
| AG | Active Comparator | Gemcitabine Plus Nab-paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surufatinib + gemcitabine + nab-paclitaxel | Drug | Neoadjuvant therapy: Surufatinib: 250mg, QD po; Nab-paclitaxel: 125mg/m2, I.V., D1/8, Q3W; Gemcitabine: 1000/m2,I.V., D1/8, Q3W. Adjuvant therapy: Gemcitabine: 1000/m2,I.V., D1/8, Q3W; Capecitabine: 1650-2000mg/(m2·d) bid, po, d1-14, Q3W. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical complete resection rate (R0) | This is a complete macroscopic resection of the gross tumor with negative surgical margins | about 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival (EFS) | The time from randomization to the first event of disease progression that precluded surgery, local or distant recurrence, or death from any cause | about 2 years |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jihui Hao, M.D. | Contact | 022-23524155 | ec_tjcih@126.com | |
| Song Gao, M.D. | Contact | foxgao2004@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jihui Hao, M.D. | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
| Song Gao, M.D. | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300000 | China |
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|
| gemcitabine + nab-paclitaxel | Drug | Neoadjuvant therapy: Nab-paclitaxel: 125mg/m2, I.V., D1/8, Q3W; Gemcitabine: 1000/m2,I.V., D1/8, Q3W. Adjuvant therapy: Gemcitabine: 1000/m2,I.V., D1/8, Q3W; Capecitabine: 1650-2000mg/(m2·d) bid, po, d1-14, Q3W. |
|
ORR= Complete response rate + partial response rate
| about 1 year |
| Disease Control Rate (DCR) | DCR= Complete response rate + partial response rate + disease stable rate | about 1 year |
| Downstaging Rate | To determine the rate of downstaging after preoperative therapy | about 1 year |
| Pathological complete response (pCR) rate | pCR is defined as the absence of residual tumor cells in the pathological examination after resection | about 1 year |
| Overall survival (OS) | Time from randomization to death | about 5 years |
| Adverse events (AEs) | treatment-related adverse events and serious adverse events as assessed by CTCAE v6.0 | about 2 years |
| ID | Term |
|---|---|
| C535836 | Pancreatic cancer, adult |
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| ID | Term |
|---|---|
| C000717729 | surufatinib |
| D000093542 | Gemcitabine |
| C520255 | 130-nm albumin-bound paclitaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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