The purpose of this clinical trial is to explore the efficacy and safety of Regorafenib combined with Toripalimab and Paclitaxel-albumin in patients as the third line treatment for patients with unresectable or metastatic pancreatic cancer.The main question it aims to answer is:
Phase Ib: Evaluate the maximum tolerated dose (MTD) of regorafenib and/or phase II clinical recommendations Dose (RP2D).
Phase II: Evaluation of the efficacy and safety of Regorafenib Combined with Terriptylimab and Albumin Paclitaxel for Late Third Line Treatment for pancreatic cancer patients.
Participants will:
Phase Ib: Selected patients will receive treatment with Regorafenib at main dose levels of 40, 80, and 120mg/d (po d1-14 Q3W), Toripalimab(240mg, ivgtt, d1, Q3W), and Paclitaxel-albumi(125mg/m2, ivgtt, d1, 8, Q3W) until disease progression or intolerable toxicity occurs.
Phase II: Regorafenib: Based on the results of the completed Phase I study, determine the dosage for Phase II (po d1-14 Q3W). Toripalimab (240mg, ivgtt, d1, Q3W) and Paclitaxel-albumi (125mg/m2, ivgtt, d1, 8, Q3W) until disease progression or intolerable toxicity occurs.
The patient fully understands this study, voluntarily participates and signs an informed consent form (ICF);
Age ≥ 18 years old and ≤ 80 years old;
Patients with unresectable/metastatic pancreatic cancer confirmed by histopathology;
Imaging confirmation of tumor progression after previous first-line and second-line standard treatment;
Have hypersensitivity reactions to any research drug or its components;
Concurrent serious uncontrolled infections or other serious uncontrolled accompanying diseases, moderate or severe kidney injury; (such as progressive infection, uncontrollable hypertension, diabetes, etc.);
Long QTc syndrome or QTc interval>480 ms;
Complete left bundle branch block, grade II or III atrioventricular block;
Junjie Hang
Lead sponsor
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Sponsor institution
Qilu Pharmaceutical Group Co., Ltd
Collaborator
Shanghai Junshi Biomedical Technology Co., Ltd
Collaborator