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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05611359
Other study ID # 2022-0698
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 2023
Est. completion date December 2026

Study information

Verified date November 2022
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact pintong huang, Doctor
Phone 0571-87783932
Email huangpintong@zju.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Thermal Ablation
Thermal hepatic ablation Combined with Chemotherapy
Drug:
Chemotherapy
Chemotherapy

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival Time from enrollment to death 2 years
Secondary Progression-free survival time Time from thermal ablation to recurrence of liver lesion 2 years
Secondary Procedure related complications Relevant complication after thermal ablation up to 12 months
Secondary Procedure related mortality up to 12 months
Secondary Patient satisfaction Satisfaction questionnaire designed by investigator group 2 years
Secondary Medical cost Hospital expenditure 2 years
Secondary Serum concentration of serological examinationof liver function Serum concentration of tunmor biomarkers 2 years
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