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NCT Number: NCT05611359

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thermal ablation

Procedure

Thermal hepatic ablation Combined with Chemotherapy

Other names: Thermal Ablation Combined with Chemotherapy

Chemotherapy

Drug

Chemotherapy

Primary outcomes

  1. Overall Survival

    Time frame: 2 years

    Time from enrollment to death

Secondary outcomes

  1. Progression-free survival time

    Time frame: 2 years

    Time from thermal ablation to recurrence of liver lesion

  2. Procedure related complications

    Time frame: up to 12 months

    Relevant complication after thermal ablation

  3. Procedure related mortality

    Time frame: up to 12 months

  4. Patient satisfaction

    Time frame: 2 years

    Satisfaction questionnaire designed by investigator group

  5. Medical cost

    Time frame: 2 years

    Hospital expenditure

  6. Serum concentration of serological examinationof liver function

    Time frame: 2 years

    Serum concentration of tunmor biomarkers

Study contacts

Contact information is provided by the study sponsor or research team.

jianting yao, Doctor

CONTACT

[email protected]

0571-87783932

pintong huang, Doctor

CONTACT

[email protected]

0571-87783932

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study 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

Acronym: HOPE-1

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 10, 2022
Registry last updated
Nov 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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