This study is a prospective, single center, single arm, phase II clinical study in patients with liver metastasis after radical resection of pancreatic cancer. The purpose of this study is to evaluate the clinical value of microwave ablation combined with chemotherapy for liver metastasis after radical resection of pancreatic cancer about overall survival, and to determine the feasibility and safety of the scheme.
Microwave ablation, as one of the important treatment methods of liver metastases, has the advantages of radical effect, small trauma and rapid recovery.Microwave ablation combined with chemotherapy aims to improve the quality of life and prolong the survival time.The purpose of this study is to evaluate the clinical value of microwave ablation combined with chemotherapy for liver metastasis after radical resection of pancreatic cancer about overall survival, and to determine the feasibility and safety of the scheme.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Microwave Ablation combination with chemotherapy. Maximum tumor diameter ≤ 3cm, single microwave needle, maximum tumor diameter\> 3cm, double ablation needle, the ablation range completely covers the lesion ≥ 0.5cm in order to obtain a satisfactory ablation margin. After the operation, contrast ultrasound is performed again to confirm the ablation edge. Enhanced MRI or CT to evaluate the ablation effect 4 weeks after surgery. Selection of chemotherapy regimen refers to the 2020 NCCN Guidelines for Pancreatic Cancer. First-line chemotherapy regimen: gemcitabine combined with albumin-bound paclitaxel or FOLFIRINOX; second-line chemotherapy regimen: If first-line chemotherapy based on gemcitabine, 5-FU-based regimen for second-line, If 5-FU-based regimen for first-line, gemcitabine for second-line.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
OS
Overall survival
Time frame: 24months
6-month PFS
From date of starting treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
Time frame: 6months
ORR
Overall Response Rate
Time frame: From the first drug administration up to two years
DCR
Disease Control Rate
Time frame: From the first drug administration up to two years
Complete ablation rate
The complete ablation rate was evaluated by abdominal enhanced MRI or CT at 4 weeks after operation
Time frame: From the first drug administration up to two years
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