This is a phase III, multi-center study to evaluate the efficacy and safety of chiauranib plus plus toripalimab, albumin-paclitaxel and gemcitabine as first-line therapy in patients with metastatic pancreatic ductal adenocarcinoma. The study includes two period: Run-in period and Randomized controlled period. The Run-in period is a single-arm, open-label study enrolling approximately 20 participants, who received the combination therapy of chiauranib plus toripalimab, albumin-paclitaxel and gemcitabine. The Randomized controlled period is a randomized, double-blind, parallel-controlled study enrolling approximately 538 participants, who are 1:1 randomly assigned to the experimental arm(chiauranib plus Toripalimab, albumin-paclitaxel and gemcitabine) or the control arm (Chiauranib placebo plus toripalimab placebo, albumin-paclitaxel and gemcitabine).
Understand and voluntarily sign the written informed consent form.
Age 18-75 years on the day of signing the informed consent form, male or female.
Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
No prior systemic therapy for metastatic pancreatic ductal adenocarcinoma. Participants who have received prior induction chemotherapy, concurrent radiotherapy, or adjuvant/neoadjuvant chemotherapy with curative intent, the interval of recurrence or metastasis must be at least 6 months after the last treatment.
Histological or cytological confirmed other pathological types, such as acinar cell carcinoma, neuroendocrine carcinoma, pancreablastoma, etc.
During screening, tumor invades major vessels (e.g., pulmonary artery, superior vena cava, or inferior vena cava) and significant risk of hemorrhage judged by the investigator; or known history of aneurysm.
Presence of active or untreated brain metastases, meningeal metastases, spinal cord compression, or leptomeningeal disease during the screening period. However, enrolment is permitted for subjects who meet the following requirements and have measurable lesion outside the CNS: asymptomatic after treatment and stable on imaging for at least 28 days prior to the first dose (e.g., no new or enlarging brain metastases) and have been off systemic glucocorticosteroids and anticonvulsant medications for at least 14 days prior to the first dose.
Presence of clinically symptomatic pleural effusion, pericardial effusion or ascites requiring frequent drainage (≥1 time/month) during the screening period.
Parallel
Chiauranib
Drug50 mg, oral administration once daily
Toripalimab Injection
Drug3mg/kg, maximum dose 240mg, administered intravenously on Days 1 and 15 of each 28-day cycle
Albumin-paclitaxel Injection
Drug125 mg/m\^2, administered intravenously on Days 1, 8 and 15 of each 28-day cycle
Gemcitabine Injection
Drug1000 mg/m\^2, administered intravenously on Days 1, 8 and 15 of each 28-day cycle
Chiauranib placebo
Drug50 mg, oral administration once daily
Toripalimab Injection placebo
Drug3mg/kg, maximum dose 240mg, administered intravenously on Days 1 and 15 of each 28-day cycle
Incidence and severity of adverse events
Defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAEV5.0)
OS
Overall survival
ORR
Objective Response Rate
DoR
Duration of Response
DCR
Disease control rate
PFS
Progression free survival
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