This trial is a prospective, single-arm, single-center Phase II clinical study aimed at evaluating the efficacy and safety of Ivonescimab combined with the gemcitabine and nab-paclitaxel (AG) regimen as neoadjuvant therapy for borderline resectable pancreatic cancer.
This trial is a prospective, single-arm, single-center Phase II clinical study aimed at evaluating the efficacy and safety of Ivonescimab combined with the gemcitabine and nab-paclitaxel (AG) regimen as neoadjuvant therapy for borderline resectable pancreatic cancer. After signing the informed consent, eligible participants will receive three cycles of Ivonescimab in combination with AG before surgery. Radical surgery will be performed within 4 to 8 weeks after the last treatment. For participants who do not meet the surgical criteria, they may continue to receive three more cycles of the same treatment. If, after six cycles, participants still do not meet the surgical criteria but have stable disease based on imaging, they may continue to receive maintenance therapy with Ivonescimab and gemcitabine/nab-paclitaxel until disease progression, death, or intolerable toxicity. After surgery, the necessity and plan for adjuvant therapy will be determined by the investigator based on the patient's condition. Imaging assessments will be conducted every three months postoperatively until disease recurrence. After recurrence, survival follow-up will be performed every three months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
All enrolled subjects will receive Ivonescimab(AK112,a PD-1/VEGF bispecific antibody,20mg/kg Q3W) in combination with gemcitabine and nab-paclitaxel
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGR0 and R1 resection rates
Defined as proportion of patients who have R0 and R1 resection
Time frame: up to 1 year
Adverse Events(AEs)
Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
Time frame: up to 3 years
Major Pathological Response(MPR)
The proportion of patients who achieve significant reduction in tumor burden as assessed by pathological examination after neoadjuvant therapy
Time frame: up to 1 year
Event-Free Survival (EFS)
The time from the start of treatment to the occurrence of a predefined event, such as disease progression, relapse, or death from any cause
Time frame: up to 2 years
Overall survival (OS)
OS is defined as the time from date of neoadjuvant treatment start to the date of death from any cause or to the date of last follow-up if patients are alive. If a patient is alive by the time of final analysis, the patient will be censored at the last follow-up date.
Time frame: up to 2 years
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