This is a multi-center, open-label， randomized controlled Phase II clinical study to observe and evaluate the efficacy and safety of Penpulimab combined with Anlotinib and Nab-paclitaxel plus Gemcitabine (PAAG ) versus AG first-line treatment in patients with metastatic pancreatic cancer.
Ages ≥18 years，ECOG ≤ 2，Estimated survival time > 3 months
Histologically or Cytologically confirmed metastatic pancreatic adenocarcinoma
Based on Response Evaluation Criteria In Solid Tumors (RECIST1.1), there should be at least one measurable lesion
Patients have never received systematical anti-cancer therapy
Patients have ever received any systematical anti-cancer therapy in the past
Patients who participated in other clinical trials in the past 4 weeks
According to the investigator, patients who surgically available or potentially treatable(Patients who voluntarily give up surgical treatment can be enrolled after evaluation by the investigator)
Patients with moderate ascites requiring drainage
Parallel
Penpulimab
DrugPenpulimab 200mg IV D1 1 cycle every 21 days
Anlotinib
DrugAnlotinib 12mg/10mg P.O. QD D1-14 (12mg for body surface area ≥1.6m2, 10mg for body surface area ≤1.6m2) 1 cycle every 21 days
Nab paclitaxel
DrugNab-paclitaxel 125mg/m2 I.V. D1,8 1 cycle every 21 days
Gemcitabine
DrugGemcitabine 1.0g/m2 I.V. D1,8 1 cycle every 21 days
Progression-free survival（PFS）
Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Objective Response Rate (ORR)
Objective response rate is defined as the percentage of subjects whose best response was complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors Criteria(RECIST v1.1)
Disease Control Rate (DCR)
Disease control rate is defined as the percentage of subjects whose best response was CR, PR or stable disease (SD) according to the RECIST v1.1
Overall Survival (OS)
Overall Survival (OS) (median) is determined using the number of months measured from the initial date of treatment to the recorded date of death of participants.
Click on the lead sponsor to view all of their trials.
