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Trial Title:
Surgery and Thermal Hepatic Ablation Combined With Chemotherapy in Hepatic Oligometastatic Pancreatic Cancer
NCT ID:
NCT05611359
Condition:
Pancreatic Ductal Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Conditions: Keywords:
Pancreatic Ductal Adenocarcinoma
Hepatic Metastasis
Thermal Ablation
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Thermal Ablation
Description:
Thermal hepatic ablation Combined with Chemotherapy
Arm group label:
Thermal Ablation
Other name:
Thermal Ablation Combined with Chemotherapy
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
Chemotherapy
Arm group label:
Chemotherapy
Arm group label:
Thermal Ablation
Summary:
The goal of this clinical trial is to compare the overall survival of thermal ablation
combined with chemotherapy and chemotherapy alone in the patients with liver
oligometastasis after pancreatic ductal adenocarcinoma (PDAC) surgery.
The main question it aims to answer is: whether thermal ablation combined with
chemotherapy can effectively prolong the overall survival in the patients with liver
oligometastasis after pancreatic ductal adenocarcinoma (PDAC) surgery.
The participants in the treatment group will receive systemic chemotherapy combined with
liver thermal ablation, while the participants in the control group will receive
chemotherapy alone. All participants will be followed up to evaluate the overall survival
after treatment.
Detailed description:
How to improve the overall survival in the patients with liver oligometastasis after
pancreatic ductal adenocarcinoma (PDAC) surgery is still a huge challenge in clinic.
Chemotherapy is still the first-line treatment for patients with liver oligometastasis
after PDAC resection. On the basis of chemotherapy, the clinical benefits of removing
hepatic oligometastasis by thermal ablation are still unclear. In this study, we will
recruit patients with liver oligometastasis after PDAC surgery to explore the effect of
thermal ablation combined with chemotherapy on the overall survival of patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- (1) Age ≥ 18; (2) pancreatic ductal adenocarcinoma was confirmed by pathology; (3)
The patient's liver function was Child Pugh A or B ; (4) Karnofsky score ≥ 80; (5)
There is a safe puncture path under the guidance of ultrasound for liver
oligometastatic tumor; (6) Single diameter of liver oligometastatic tumor ≤ 5 cm, or
≤ 3 liver oligometastatic tumors, each diameter ≤ 3 cm; (7) Platelet
count>40000/mm3; (8) Thrombin time ratio>40%; (9) Sign the Informed Consent of
Clinical Trial.
Exclusion Criteria:
- (1) Refuse to receive chemotherapy or thermal ablation; (2) >3 liver metastases or
extrahepatic metastases (such as peritoneum, lung, bone or brain); (3) Single
diameter of liver oligometastatic tumor>5 cm; (4) The patient has ascites, portal
vein thrombosis, or bile duct dilatation or stenosis; (5) Presence of another
malignant tumors; (6) Prior anti-tumor treatment (including radiotherapy,
chemotherapy and thermal ablation); (7) Presence of central nervous system
abnormalities, mental diseases, unstable angina, congestive heart failure, serious
arrhythmia or other serious diseases; (8) Use of anticoagulants maintenance
treatment.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
January 2023
Completion date:
December 2026
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05611359
