The purpose of this study is to look at the efficacy and safety of HR070803 in combination with 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
778
HR070803 in combination with oxaliplatin, 5-fluorouracil, calcium folinate
nab-paclitaxel in combination with gemcitabine
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGOverall survival (OS)
Time frame: From study start until 399 OS events have occurred (approximately 15 months after last patient enrollment)
Objective Response rate (ORR)
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.
Time frame: up to 6 months following the date the last patient was randomized
Disease Control Rate
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).
Time frame: up to 6 months following the date the last patient was randomized
Duration of Response
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.
Time frame: up to 6 months following the date the last patient was randomized
Progression free survival (PFS)
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.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.