To evaluate the safety and efficacy of HRS-4642 in Combination With AG and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer
This study is an open, single center, exploratory clinical trial aimed at evaluating the safety and efficacy of HRS-4642 in combination with gemcitabine and albumin-bound paclitaxel and Adebrelimab for neoadjuvant and adjuvant treatment of pancreatic cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel and Adebrelimab will be administrated per dose level in which the patients are assigned.
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China
RECRUITINGAdverse events (AEs)
AEs are assessed by NCI-CTCAE v5.0
Time frame: From the first drug administration to within 30 days for the last dose
Objective Response Rate (ORR)
Evaluated by RECIST v1.1
Time frame: Up to approximately 6 months
pathologic complete response (pCR)
Number of subjects achieving pCR as a percentage of subjects
Time frame: At the time of surgery
Overall survival (OS)
Time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive.
Time frame: Up to approximately 12 months
major pathologic response (MPR, CAP Score 0-1)
Number of Subjects Achieving MPR as a Percentage of Subjects
Time frame: At the time of surgery
Disease-free survival (DFS)
For subjects who achieved R0/R1 resection, the time from the start of surgery to disease recurrence (local or distant) or death from any cause, whichever occurs first
Time frame: Up to approximately 6 months
Event-free survival (EFS)
The time from the first dose of neoadjuvant therapy to the occurrence of any event; events include the occurrence of imaging disease progression (based on the date of the imaging test), the occurrence of disease recurrence (local recurrence or distant recurrence) after surgery, and death from any cause, based on the time of the first occurrence
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Time frame: Up to approximately 6 months