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This study is being conducted to explore the efficacy and safety of SHR-1020 combined with albumin-bound paclitaxel in the second-line treatment of advanced pancreatic cancer.
This trial is a prospective, single-center, single-arm clinical research. Advanced pancreatic cancer is an aggressive disease with extremely low 5-year survival rate. For advanced pancreatic cancer patients who failed with first-line treatment, subsequent treatment options are limited. SHR-1020 combined with albumin-bound paclitaxel could through multiple mechanisms such as block tumor mitosis, inhibit tumor angiogenesis, inhibit interstitial fibrosis to achieve anti-tumor effect.
The safety and efficacy of this study will be assessed through ORR, DCR,PFS, OS , and adverse effects as graded by CTCAE 5.0.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1020 combined with albumin-bound paclitaxel | Experimental | SHR-1020 combined with albumin-bound paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1020+albumin-bound paclitaxel | Drug | SHR-1020 combined with albumin-bound paclitaxel for advanced pancreatic cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR (Objective Response Rate) | Containing the incidence of complete response (CR) and partial response (PR). Evaluated according to RECIST 1.1 criteria,subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles. | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months] |
| Measure | Description | Time Frame |
|---|---|---|
| DCR (Disease Control Rate) | Containing the incidence of complete response (CR), partial response (PR) and stable disease (SD).Evaluated according to RECIST 1.1 criteria,subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles. | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months] |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300000 | 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 |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
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|
| PFS (Progression-Free-Survival) | From date of treatment start until the date of progression or the date of death due to any cause.Evaluated according to RECIST 1.1 criteria,subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles. | From date of treatment start until the date of progression or the date of death due to any caus, assessed up to 12 months |
| 6mPFS | 6-month- Progression-Free-Survival rate. Evaluated according to RECIST 1.1 criteria,subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles. | Up to 6 months |
| OS (overall survival) | From date of treatment start to any cause death or last follow-up. | From date of treatment start until the date of death from any cause or censored at the last day that the patient is documented to be alive, whichever came first, assessed up to 12 months |
| Adverse events (per CTCAE v5.0 criteria) | To evaluate the adverse events of patients with advanced pancreatic cancer after treated with SHR-1020 plus albumin-bound paclitaxel | Up to 12months |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |