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

Trial ID: NCT06361888

Interventional - Phase 2/3 - Recruiting

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

Conditions

• Metastatic Pancreatic Cancer

Interventions

• Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine
• Nab-paclitaxel Plus Gemcitabine
• Surufatinib with Nab-paclitaxel, and Gemcitabine

Eligibility

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;

Sponsor

Hutchmed

Source: ClinicalTrials.gov

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