A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer

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

To evaluate the efficacy of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer

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

Inclusion Criteria:

1. Fully understand and voluntarily sign an informed consent form, willing and able to follow the study process;
2. Age range is 18-75 years old (inclusive);
3. Pancreatic cancer confirmed by histology or cytology;
4. Stage IV metastasis Pancreatic cancer patients;
5. Have not received previous systematic first line anti-tumor treatment in the stage of metastatic pancreatic cancer;
6. According to RECIST 1.1, there is at least one measurable lesion;
7. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1;
8. Expected survival time ≥ 12 weeks;

Exclusion Criteria:

1. Use of systematic non-specific immunomodulatory therapy within 2weeks prior to the first dose；
2. Presence of other malignancies in the past 5 years;
3. Received major surgical surgery within 4 weeks before the first dose;
4. Received palliative radiotherapy within 1 week before the first dose; received radical radiotherapy within 4 weeks before the first dose;
5. Any known allergy to surufatinib or its components, camrelizumab, nab-paclitaxel, or gemcitabine;
6. Received strong-inducers or strong-inhibitors of cytochrome P450 (CYP) 3A within 2 weeks or 5 half-lives (whichever is longer) before the first dose;
7. Use of immunosuppressive drugs within 4 weeks before first dose;
8. Known history of clinically significant liver disease, including active viral hepatitis infection or other active hepatitis or clinically significant moderate to severe cirrhosis;
9. Patients who currently have hypertension that cannot be controlled by medication;