NCT04677192

Microwave Ablation Combined With Chemotherapy in the Treatment of Pancreatic Cancer Oligohepatic Metastasis

Effectiveness and Safety Evaluation of Microwave Ablation Combined With Chemotherapy in the Treatment of Pancreatic Cancer Oligohepatic Metastasis: A Prospective, Single-center, Single-arm, Phase II Clinical Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pancreatic Cancer Metastatic to Liver
• Oligometastasis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Microwave Ablation combination with chemotherapy	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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-01-01
• Completion: 2022-12-01
• First posted: 2020-12-21
• Last updated: 2020-12-21

Locations

1 site across 1 country: China