A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine 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
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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;
You may not be if
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;
Clareo Health | A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer
