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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
To evaluate the efficacy of Surufatnib combined withcamrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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 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;
Locations
Other Locations
China
Nanjing Tianyinshan Hospital
NOT_YET_RECRUITING
Nanjing
Tianjin Cancer Hospital
RECRUITING
Tianjin
Contact Information
Primary
Panfeng Tan
panfengt@hutch-med.com
+86 21 20671828
Time Frame
Start Date: 2024-05-08
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 552
Treatments
Experimental: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine
Active_comparator: Nab-paclitaxel Plus Gemcitabine
Other: Surufatinib with Nab-paclitaxel, and Gemcitabine
Related Therapeutic Areas
Sponsors
Leads: Hutchmed