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Surgery and Thermal Hepatic Ablation Combined With Chemotherapy in Hepatic Oligometastatic Pancreatic Cancer (HOPE-1)

Primary Purpose

Pancreatic Ductal Adenocarcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Thermal Ablation
Chemotherapy
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Ductal Adenocarcinoma focused on measuring Pancreatic Ductal Adenocarcinoma, Hepatic Metastasis, Thermal Ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Thermal Ablation

    Chemotherapy

    Arm Description

    In the patients with liver oligometastasis after pancreatic ductal adenocarcinoma (PDAC) surgery, thermal ablation and chemotherapy are administered.

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

    Outcomes

    Primary Outcome Measures

    Overall Survival
    Time from enrollment to death

    Secondary Outcome Measures

    Progression-free survival time
    Time from thermal ablation to recurrence of liver lesion
    Procedure related complications
    Relevant complication after thermal ablation
    Procedure related mortality
    Patient satisfaction
    Satisfaction questionnaire designed by investigator group
    Medical cost
    Hospital expenditure
    Serum concentration of serological examinationof liver function
    Serum concentration of tunmor biomarkers

    Full Information

    First Posted
    November 6, 2022
    Last Updated
    November 9, 2022
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05611359
    Brief Title
    Surgery and Thermal Hepatic Ablation Combined With Chemotherapy in Hepatic Oligometastatic Pancreatic Cancer
    Acronym
    HOPE-1
    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

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    December 2026 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pancreatic Ductal Adenocarcinoma
    Keywords
    Pancreatic Ductal Adenocarcinoma, Hepatic Metastasis, Thermal Ablation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Thermal Ablation
    Arm Type
    Experimental
    Arm Description
    In the patients with liver oligometastasis after pancreatic ductal adenocarcinoma (PDAC) surgery, thermal ablation and chemotherapy are administered.
    Arm Title
    Chemotherapy
    Arm Type
    Active Comparator
    Arm Description
    In the patients with liver oligometastasis after pancreatic ductal adenocarcinoma (PDAC) surgery, chemotherapy is administered.
    Intervention Type
    Procedure
    Intervention Name(s)
    Thermal Ablation
    Other Intervention Name(s)
    Thermal Ablation Combined with Chemotherapy
    Intervention Description
    Thermal hepatic ablation Combined with Chemotherapy
    Intervention Type
    Drug
    Intervention Name(s)
    Chemotherapy
    Intervention Description
    Chemotherapy
    Primary Outcome Measure Information:
    Title
    Overall Survival
    Description
    Time from enrollment to death
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Progression-free survival time
    Description
    Time from thermal ablation to recurrence of liver lesion
    Time Frame
    2 years
    Title
    Procedure related complications
    Description
    Relevant complication after thermal ablation
    Time Frame
    up to 12 months
    Title
    Procedure related mortality
    Time Frame
    up to 12 months
    Title
    Patient satisfaction
    Description
    Satisfaction questionnaire designed by investigator group
    Time Frame
    2 years
    Title
    Medical cost
    Description
    Hospital expenditure
    Time Frame
    2 years
    Title
    Serum concentration of serological examinationof liver function
    Description
    Serum concentration of tunmor biomarkers
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    pintong huang, Doctor
    Phone
    0571-87783932
    Email
    huangpintong@zju.edu.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    jianting yao, Doctor
    Phone
    0571-87783932
    Email
    yaojianting@zju.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    pintong huang, Doctor
    Organizational Affiliation
    the 2th affiliated hospital of zhejiang university school of medicine
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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