Surgery And Thermal Hepatic Ablation Combined With Chemotherapy In Hepatic Oligometastatic Pancreatic Cancer

Study Overview

Surgery and Thermal Hepatic Ablation Combined With Chemotherapy in Hepatic Oligometastatic Pancreatic Cancer

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.

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.

Pancreatic Ductal Adenocarcinoma

PROCEDURE: Thermal Ablation
DRUG: Chemotherapy

2022-0698

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-11-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-11-09
First Submitted that Met QC Criteria 2022-11-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-11-10
First Posted (ACTUAL) 2022-11-10	Results First Posted N/A	Last Verified 2022-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/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 DRUG: Chemotherapy Chemotherapy
ACTIVE_COMPARATOR: Chemotherapy In the patients with liver oligometastasis after pancreatic ductal adenocarcinoma (PDAC) surgery, chemotherapy is administered.	DRUG: Chemotherapy Chemotherapy

Participant Group/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

DRUG: Chemotherapy

Chemotherapy

ACTIVE_COMPARATOR: Chemotherapy

In the patients with liver oligometastasis after pancreatic ductal adenocarcinoma (PDAC) surgery, chemotherapy is administered.

DRUG: Chemotherapy

Chemotherapy

Primary Outcome Measures	Measure Description	Time Frame
Overall Survival	Time from enrollment to death	2 years

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: pintong huang, Doctor

Phone Number: 0571-87783932

Email: huangpintong@zju.edu.cn

Study Contact Backup

Name: jianting yao, Doctor

Phone Number: 0571-87783932

Email: yaojianting@zju.edu.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

(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.

(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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: pintong huang, Doctor, the 2th affiliated hospital of zhejiang university school of medicine

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record