First-line Treatment of Metastatic Pancreatic Cancer
Conditions
Brief summary
This study is a randomized, open-label, multicenter Phase III clinical trial designed to evaluate the efficacy and safety of Irinotecan Hydrochloride Liposome Injection (II) combined with oxaliplatin and 5-FU/LV versus nab-paclitaxel combined with gemcitabine as first-line treatment for advanced pancreatic cancer.
Interventions
DRUGIrinotecan Hydrochloride Liposome Injection (II); Oxaliplatin; 5Fluorouracil; Calcium folinate
Irinotecan Hydrochloride Liposome Injection (II) in combination with oxaliplatin, 5-fluorouracil, calcium folinate
nab-paclitaxel in combination with gemcitabine
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. ECOG performance status 0 or 1 2. Histological or cytologically confirmed pancreatic cancer that has not been previously treated in the metastatic disease. 3. Life expectancy of greater than or equal to3 months. 4. At least one measurable lesion is present according to the efficacy evaluation criteria for pancreatic cancer (RECIST 1.1) 5. Able and willing to provide a written informed consent
Exclusion criteria
1. Patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor; 2. Known history of central nervous system (CNS) metastases. 3. Severe infection (\> CTCAE grade 2), such as severe pneumonia, bacteremia, infection complications, etc. requiring inpatient treatment, occurred within four weeks before enrollment, and symptoms and signs of infection requiring intravenous antibiotic therapy (except for prophylactic antibiotics) occurred within two weeks before enrollment; 4. Patients with cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Patients with NYHA class 2 and above cardiac failure; (2) unstable angina; (3) myocardial infarction that occurred within 6 months; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | From study start until target OS events have occurred (approximately 18 months after last patient enrollment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response rate (ORR) | up to 6 months following the date the last patient was randomized | ORR is defined as the percentage of participants who have a best overall response of complete response (CR) or partial response (PR), per RECIST 1.1. |
| Disease Control Rate | up to 6 months following the date the last patient was randomized | The study is designed to evaluate the disease control rate with advanced pancreatic cancer. DCR is defined as the percentage of patients with a best response of CR, PR, or stable disease (SD). |
| Duration of Response | up to 6 months following the date the last patient was randomized | DoR is defined as the time from first documentation of response (CR or PR whichever occurred first, as per RECIST version 1.1) to disease progression or death, whichever is earlier. |
| Progression free survival (PFS) | From the date of first dose of study drug until progressive disease (PD), death, whichever occurs first,assessed up to 18 months | PFS is defined as the time from the date of first dose of study drug to the date of the first documentation of disease progression or date of death, whichever occurs first. |
Countries
China
Contacts
Primary ContactZengquan Gu
Outcome results
None listed