Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is being conducted to evaluate the efficacy, safety and tolerability of SHR6390 in combination with nab-paclitaxel and gemcitabine in first-line treatment of subjects with advanced/metastatic pancreatic cancer.
This is an open-label, prospective, single-center, single-arm, Simon's two-stage design phase II study for unresectable advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) subjects treated with SHR6390 plus nab-paclitaxel and gemcitabine.
In this research study, the main objectives include:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AG+SHR6390 | Experimental | Subjects will receive SHR6390 plus nab-paclitaxel and gemcitabine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR6390 | Drug | SHR6390, Oral Administration |
| |
| Nab-paclitaxel |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as the proportion of patients with best objective response of confirmed complete response (CR) or partial response (PR) according to RECIST1.1. | Up to 2 years. |
| Adverse Events (AEs) | AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0. | From the first drugs administration to within 30 days for the last treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from the first drugs administration to the date of death due to any cause or the last follow ship. | Up to 2 years. |
| Progression Free Survival (PFS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Baiyong Shen, Ph.D&M.D | Contact | 008613901943778 | shenby@shsmu.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Paclitaxel-albumin, Intravenous Injection |
|
| Gemcitabine | Drug | Gemcitabine, Intravenous Injection |
|
PFS is defined as the time from the first drugs administration to the date of disease progression or the last follow ship.
| Up to 2 years. |
| Disease Control Rate (DCR) | DCR is defined as the rate of participants who have achieved complete response, partial response and stable disease. | Up to 2 years. |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |