HOPE-1: Surgery and Thermal Hepatic Ablation Combined With Chemotherapy in Hepatic Oligometastatic Pancreatic Cancer
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Thermal Ablation In the patients with liver oligometastasis after pancreatic ductal adenocarcinoma (PDAC) surgery, thermal ablation and chemotherapy are administered. |
Procedure: Thermal Ablation
Thermal hepatic ablation Combined with Chemotherapy
Other Names:
Drug: Chemotherapy
Chemotherapy
|
Active Comparator: Chemotherapy In the patients with liver oligometastasis after pancreatic ductal adenocarcinoma (PDAC) surgery, chemotherapy is administered. |
Drug: Chemotherapy
Chemotherapy
|
Outcome Measures
Primary Outcome Measures
- Overall Survival [2 years]
Time from enrollment to death
Secondary Outcome Measures
- Progression-free survival time [2 years]
Time from thermal ablation to recurrence of liver lesion
- Procedure related complications [up to 12 months]
Relevant complication after thermal ablation
- Procedure related mortality [up to 12 months]
- Patient satisfaction [2 years]
Satisfaction questionnaire designed by investigator group
- Medical cost [2 years]
Hospital expenditure
- Serum concentration of serological examinationof liver function [2 years]
Serum concentration of tunmor biomarkers
Eligibility Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
- Study Chair: pintong huang, Doctor, the 2th affiliated hospital of zhejiang university school of medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-0698