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.
A total of 50 participants are expected to be enrolled in this study; 25 will receive the surufatinib and serplulimab in conjunction with albumin-paclitaxel and gemcitabine regimen and 25 will receive the AG regimen. The participants who have been enrolled will initially undergo two cycles of albumin-paclitaxel and gemcitabine induction chemotherapy. The researcher will assess the patients' efficacy based on their imaging results after the second cycle. Patients with PD will be excluded from this trial, and patients with SD, PR, or CR will be enrolled. Patients will be randomly chosen to receive either the AG regimen for 2-4 cycles or the surufatinib combined with serplulimab and AG regimen for 2-4 cycles. Every two cycles, the researcher assessed the effectiveness of the patients' treatments and the potential for R0 resection. Then, patients with PD were removed from the group, those who could be operated were enrolled for surgical resection, and those without PD and unable to undergo surgery were finished with a total of 6 cycles of either the AG regimen chemotherapy or surufatinib combined with serplulimab and the AG regimen chemotherapy. Within 12 weeks of surgery, patients underwent 0-2 cycles of chemotherapy with the AG regimen or surufatinib combined with serplulimab and AG regimen, totaling 6 cycles of postoperative chemotherapy. Then patients of AG group will enter follow up stage. Patients with R0 resection will accept surufatinib in combination with serplulimab maintenance for no longer than 12 cycles after surgery, or until intolerability, progressive disease, death, or other criteria for study treatment discontinuation specified in the protocol, whichever comes first. Patients who have not progressed and are unable to undergo surgery, or who accepted R1 or R2 resection, after six cycles of the surufatinib combination with serplulimab and AG regimen, will receive sulfatinib combined with serplulimab maintenance therapy for a maximum of 29 cycles, or until intolerance, disease progression, death, or other criteria specified in the study protocol were met.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Surufatinib: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: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
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
R0 Surgical Resection Rate
Proportion of patients with negative microscopic margins (no tumor cell remains)
Time frame: Up to 2 years
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%.
Time frame: Up to 2 years
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
Time frame: Up to 2 years
Deepness of response (DpR)
DpR is defined as the percentage of maximal tumor reduction from baseline of a target lesion.
Time frame: Up to 2 years
Progression-Free Survival (PFS)
PFS is defined as the time from the first dose of administration to progression or death
Time frame: Up to 2 years
Disease-free survival (DFS)
DFS is defined as the time interval between the date of enrollment and the date of the first documented evidence of relapse after radical resection at any site or death related to cancer
Time frame: Up to 2 years
Over Survival (OS)
OS is defined as the time from first treatment to death, regardless of disease recurrence
Time frame: Up to 2 years
Quality of Life (QOL)
Acording the EORTC QLQ-C30.
Time frame: Up to 2 years
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