Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2025-12-27 @ 2:05 PM
Study NCT ID:
NCT05611359
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-11-10
First Post:
2022-11-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgery and Thermal Hepatic Ablation Combined With Chemotherapy in Hepatic Oligometastatic Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020728', 'term': 'Transurethral Resection of Prostate'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D011468', 'term': 'Prostatectomy'}, {'id': 'D013521', 'term': 'Urologic Surgical Procedures, Male'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-09', 'studyFirstSubmitDate': '2022-11-06', 'studyFirstSubmitQcDate': '2022-11-09', 'lastUpdatePostDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '2 years', 'description': 'Time from enrollment to death'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival time', 'timeFrame': '2 years', 'description': 'Time from thermal ablation to recurrence of liver lesion'}, {'measure': 'Procedure related complications', 'timeFrame': 'up to 12 months', 'description': 'Relevant complication after thermal ablation'}, {'measure': 'Procedure related mortality', 'timeFrame': 'up to 12 months'}, {'measure': 'Patient satisfaction', 'timeFrame': '2 years', 'description': 'Satisfaction questionnaire designed by investigator group'}, {'measure': 'Medical cost', 'timeFrame': '2 years', 'description': 'Hospital expenditure'}, {'measure': 'Serum concentration of serological examinationof liver function', 'timeFrame': '2 years', 'description': 'Serum concentration of tunmor biomarkers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic Ductal Adenocarcinoma', 'Hepatic Metastasis', 'Thermal Ablation'], 'conditions': ['Pancreatic Ductal Adenocarcinoma']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* (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.\n\nExclusion Criteria:\n\n* (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."}, 'identificationModule': {'nctId': 'NCT05611359', 'acronym': 'HOPE-1', 'briefTitle': 'Surgery and Thermal Hepatic Ablation Combined With Chemotherapy in Hepatic Oligometastatic Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Resection of the Primary Pancreatic Tumour and Thermal Hepatic Ablation Combined With Chemotherapy vs. Chemotherapy in Hepatic Oligometastatic Pancreatic Cancer: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2022-0698'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thermal Ablation', 'description': 'In the patients with liver oligometastasis after pancreatic ductal adenocarcinoma (PDAC) surgery, thermal ablation and chemotherapy are administered.', 'interventionNames': ['Procedure: Thermal Ablation', 'Drug: Chemotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chemotherapy', 'description': 'In the patients with liver oligometastasis after pancreatic ductal adenocarcinoma (PDAC) surgery, chemotherapy is administered.', 'interventionNames': ['Drug: Chemotherapy']}], 'interventions': [{'name': 'Thermal Ablation', 'type': 'PROCEDURE', 'otherNames': ['Thermal Ablation Combined with Chemotherapy'], 'description': 'Thermal hepatic ablation Combined with Chemotherapy', 'armGroupLabels': ['Thermal Ablation']}, {'name': 'Chemotherapy', 'type': 'DRUG', 'description': 'Chemotherapy', 'armGroupLabels': ['Chemotherapy', 'Thermal Ablation']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'pintong huang, Doctor', 'role': 'CONTACT', 'email': 'huangpintong@zju.edu.cn', 'phone': '0571-87783932'}, {'name': 'jianting yao, Doctor', 'role': 'CONTACT', 'email': 'yaojianting@zju.edu.cn', 'phone': '0571-87783932'}], 'overallOfficials': [{'name': 'pintong huang, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'the 2th affiliated hospital of zhejiang university school of medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}