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: 1. Evaluate objective response rate in patients with pancreatic cancer receiving SHR6390 plus nab-paclitaxel and gemcitabine. 2. Assess adverse side effects associated with the combination of SHR6390 with nab-paclitaxel and gemcitabine.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
SHR6390, Oral Administration
Paclitaxel-albumin, Intravenous Injection
Gemcitabine, Intravenous Injection
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
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.
Time frame: 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.
Time frame: From the first drugs administration to within 30 days for the last treatment.
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.
Time frame: Up to 2 years.
Progression Free Survival (PFS)
PFS is defined as the time from the first drugs administration to the date of disease progression or the last follow ship.
Time frame: 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.
Time frame: Up to 2 years.
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