This research study is a Phase 2 clinical trial. It will test the efficiency and safety of an investigational drug of Anlotinib (a small molecular anti-VEGF TKI) with PD-1 inhibitor in second-line therapy with the goal of determining the OS of metastatic pancreatic adenocarcinoma. Subjects must have a stage 4 untreated metastatic pancreatic ductal cancer failed to first-line chemotherapy and meet all inclusion/exclusion criteria. Treatment consists of treatment with anlotinib 8-12 mg oral, day 1-14, and PD-1 inhibitor 200 mg iv, every 21 days each cycle. Treatment will be administered until untolerable toxicities or progression or subject death, or either the subject or sponsor discontinues the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Anlotinib, 8-12 mg/day, orally, day 1-14; PD-1 inhibitor 200 mg iv, every 21 days one cycle
Qingdao central Hospital
Qingdao, Shandong, China
RECRUITINGQingdao central Hospital
Qingdao, Shandong, China
RECRUITINGThe overall survival in this population of patients
The overall survival of the enrolled patients from start the combination treatment of anlotinib and PD-1 inhibitor
Time frame: 24 months
The progression free survival in this population of patients
The progression free survival of the enrolled patients from start the combination treatment with anlotinib and PD-1 inhibitor
Time frame: 24 months
The response rate in this population of patients
Number of participants with clinical response assessed by RECIST 1.1 criteria on imaging every 4 weeks with the combination of anlotinib and PD-1 inhibitor
Time frame: Up to 48 months
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