A Phase Ⅱ Study of Chiauranib Plus Albumin-paclitaxel and Gemcitabine as First-line Therapy in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma
Chiauranib , which simultaneously targets against VEGFR/Aurora B/CSF-1R, several key kinases involved in tumor angiogenesis, tumor cell mitosis, and chronic inflammatory microenvironment.
• 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 unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma.
• No prior systemic therapy for unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma. Subjects 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.
• At least one measurable lesion according to RECIST v1.1. Previously irradiated lesions should not be selected as target lesions unless the previously irradiated lesion as the only measurable lesion and is unequivocally progressive based on imaging.
• ECOG score 0 or 1.
• Life expectancy≥3 months.
• Major organ functions meet the following criteria: Hematology: hemoglobin≥90g/L, absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelets≥100×10\^9/L(no haematopoietic growth factors or blood transfusions and other medications considered by the investigator to be corrective therapy, within 2 weeks before enrollment). Biochemistry: serum creatinine≤1.5×ULN, total bilirubin≤1.5×ULN, AST/ALT≤2.5×ULN (≤5×ULN for patients with hepatic metastasis). Coagulation Function: INR \< 1.5×ULN.