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NCT06361888
A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer
Conditions: Metastatic Pancreatic Cancer
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 502
Sponsor: Hutchmed
Location: Anhui Provincial Hospital Hefei Anhui
Summary
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
Eligibility Criteria
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;
Source: ClinicalTrials.gov (NCT06361888). StuddyBuddy aggregates publicly available trial information.