A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer
Recruiting now · Phase 2/Phase 3
Conditions studied: Metastatic Pancreatic Cancer
In brief
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
Key facts
- Study ID
- NCT06361888
- Run by
- Hutchmed
- People needed
- 502
- Starts
- 2024-05-08
- Expected to finish
- 2028-05-31
- Last updated by the study team
- 2026-05-28
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 first line 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;
You may not qualify if…
- Use of systematic non-specific immunomodulatory therapy within 2weeks prior to the first dose；
- Presence of other malignancies in the past 5 years;
- Received major surgical surgery within 4 weeks before the first dose;
- 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 strong-inducers or strong-inhibitors of cytochrome P450 (CYP) 3A 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;
Where it is running
- Tianjin Cancer Hospital — Tianjin, Tianjin Municipality, China (enrolling)
- Nanjing Tianyinshan Hospital — Nanjing, Jiangsu, China
Full record on ClinicalTrials.gov
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