This is a Phase II Randomized Controlled PILOT clinical study. The purpose of this study is to explore the efficacy and safety of surufatinib and serplulimab in combination with albumin-paclitaxel and gemcitabine in the conversion therapy for patients with unresectable locally advanced pancreatic cancer. Furthermore, it compares the efficacy of surufatinib and serplulimab in combination with albumin-paclitaxel and gemcitabine to the albumin-paclitaxel and gemcitabine regimen in the conversion therapy for patients with unresectable locally advanced pancreatic cancer.
Written informed consent obtained from the patient prior to treatment.
Pathologically confirmed unresectable locally advanced pancreatic cancer, received no surgical therapy.
Age between 18 and 75 years at the time of study entry.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
Participants diagnosed pancreatic cancer with distant metastases.
Participation in other antineoplastic drug clinical trials within 4 weeks prior to enrollment;
Previous systemic antitumor therapy (chemotherapy, radiation, targeted or immunoth, etc.).
Diagnosis of any second malignancy, except for adequately treated basal cell skin cancer or in situ carcinoma of the cervix uteri.
Parallel
Surufatinib + Serplulimab+Albumin-paclitaxel + Gemcitabine
DrugSurufatinib:250mg orally once a day for 3 weeks(3 weeks 1 cycle) Serplulimab:4.5mg/Kg by intravenous infusions on day1 every 3 weeks Albumin-paclitaxel:125mg/m2 by intravenous infusions on day1 and 8 every 3 weeks Gemcitabine:1000mg/m2 by intravenous infusions on day1 and 8 every 3 weeks
Albumin-paclitaxel + Gemcitabine
DrugAlbumin-paclitaxel:125mg/m2 by intravenous infusions on day1 and 8 every 3 weeks Gemcitabine:1000mg/m2 by intravenous infusions on day1 and 8 every 3 weeks
R0 Surgical Resection Rate
Proportion of patients with negative microscopic margins (no tumor cell remains)
Surgical conversion rate
Surgical conversion rate: the proportion of patients with successful conversion and surgical resection in all patients, surgical conversion rate =(number of patients with successful conversion and surgical resection/total number of patients) ×100%.
Objective response rate (ORR)
ORR is defined as the percentage of patients who have achieved complete response (CR) or partial response (PR), as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Deepness of response (DpR)
DpR is defined as the percentage of maximal tumor reduction from baseline of a target lesion.
Progression-Free Survival (PFS)
PFS is defined as the time from the first dose of administration to progression or death
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