Overview
To evaluate the efficacy of Surufatnib combined withcamrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer
Description
This is a multicenter, randomized, open-label, active-controlled, phase II/III trial to evaluate the efficacy and safety of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer
Eligibility
Inclusion Criteria:
- Fully understand and voluntarily sign an informed consent form, willing and able to follow the study process;
- Age range is 18-75 years old (inclusive);
- Pancreatic cancer confirmed by histology or cytology;
- Stage IV metastasis Pancreatic cancer patients;
- Have not received previous systematic anti-tumor treatment in the stage of metastatic pancreatic cancer;
- According to RECIST 1.1, there is at least one measurable lesion;
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1;
- Expected survival time ≥ 12 weeks;
Exclusion Criteria:
- Use of systematic anti-tumor therapy within 4 weeks prior to the first dose;
- Presence of other malignancies in the past 3 years;
- Received major surgical surgery within 60 days before the first dose;
- Have received any surgery or invasive treatment within 4 weeks before the first use of the drug;
- Received palliative radiotherapy within 1 week before the first dose; received radical radiotherapy within 4 weeks before the first dose;
- Any known allergy to surufatinib or its components, camrelizumab, nab-paclitaxel, or gemcitabine;
- Received inducers or inhibitors of cytochrome P450 (CYP) 3A and CYP2C8 within 2 weeks or 5 half-lives (whichever is longer) before the first dose;
- Use of immunosuppressive drugs within 4 weeks before first dose;
- Known history of clinically significant liver disease, including active viral hepatitis infection or other active hepatitis or clinically significant moderate to severe cirrhosis;
- Patients who currently have hypertension that cannot be controlled by medication;