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This is a single-center, open-label, exploratory study aims to assess the efficacy and safety of QL1706 plus nab-paclitaxel and gemcitabine as first-line treatment for patients with metastatic pancreatic adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL1706, Chidamide, Albumin-bound Paclitaxel and Gemcitabine | Experimental | QL1706 5mg/kg,Q3W; Gemcitabine 1000mg/m2 Q3W;Nab-paclitaxel 125mg/m2 Q3W; Chidamide, 20mg biw q3w; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1706 | Drug | 5mg/kg, q3w |
| |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | overall response rate | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| OS | OS is defined as the time from date of treatment start to the date of death from any cause or to the date of last follow-up if patients are alive. If a patient is alive by the time of final analysis, the patient will be censored at the last follow-up date. | 2 year |
| AEs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui Liu, MD | Contact | 13602139003 | liurui9003@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Rui Liu | Tianjin Medical University Cancer Institute and Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | 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 |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| D000093542 | Gemcitabine |
| C520255 | 130-nm albumin-bound paclitaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Chidamide |
| Drug |
20mg, biw, q3w |
|
| Gemcitabine | Drug | 1000mg/m2 Q3W |
|
| Nab-paclitaxel | Drug | 125mg/m2 Q3W |
|
Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0 |
| 2 year |
| Progression-free Survival (PFS) | PFS was assessed by investigators per RECIST 1.1 | 2 year |
| Disease Control Rate (DCR) | DCR was assessed by investigators per RECIST 1.1 | 2 year |
| Duration of Response (DOR) | DOR was assessed by investigators per RECIST 1.1 | 2 year |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |