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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05611359
Collaborator
(none)
60
2
47

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

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2026
Anticipated Study Completion Date :
Dec 1, 2026

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:
  • Thermal 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

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival [2 years]

      Time from enrollment to death

    Secondary Outcome Measures

    1. Progression-free survival time [2 years]

      Time from thermal ablation to recurrence of liver lesion

    2. Procedure related complications [up to 12 months]

      Relevant complication after thermal ablation

    3. Procedure related mortality [up to 12 months]

    4. Patient satisfaction [2 years]

      Satisfaction questionnaire designed by investigator group

    5. Medical cost [2 years]

      Hospital expenditure

    6. Serum concentration of serological examinationof liver function [2 years]

      Serum concentration of tunmor biomarkers

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.
    Responsible Party:
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT05611359
    Other Study ID Numbers:
    • 2022-0698
    First Posted:
    Nov 10, 2022
    Last Update Posted:
    Nov 10, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 10, 2022