Clinical trial NCT05611359: Surgery and Thermal Hepatic Ablation Combined With Chemotherapy in Hepatic Oligometastatic Pancreatic Cancer
Official title: Resection of the Primary Pancreatic Tumour and Thermal Hepatic Ablation Combined With Chemotherapy vs. Chemotherapy in Hepatic Oligometastatic Pancreatic Cancer: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pancreatic Ductal Adenocarcinoma
Keywords: Pancreatic Ductal Adenocarcinoma
Hepatic Metastasis
Thermal Ablation
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Overall Survival
timeFrame: 2 years
Secondary outcomes:
measure: Progression-free survival time
timeFrame: 2 years
measure: Procedure related complications
timeFrame: up to 12 months
measure: Procedure related mortality
timeFrame: up to 12 months
measure: Patient satisfaction
timeFrame: 2 years
measure: Medical cost
timeFrame: 2 years
measure: Serum concentration of serological examinationof liver function
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: the 2th affiliated hospital of zhejiang university school of medicine
name: pintong huang, Doctor
role: STUDY_CHAIR
References: