Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 8:31 AM
Study NCT ID:
NCT07428356
Status:
RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Histotripsy for Ablation of Liver Tumours in Asia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Patients will undergo baseline imaging and laboratory investigations, followed by histotripsy treatment under general anaesthesia.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Histotripsy treatment.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-05-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-19', 'studyFirstSubmitDate': '2026-02-06', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Longitudinal Response Evaluation and patterns of progression.', 'timeFrame': '3 months, 6 months, 1 year and 2 years post-procedure.', 'description': 'Percentage change of tumour sizes from baseline to each of the timepoints specified in the protocol. Pattern of progression will be tabulation (frequency + percentages) of the pattern of progression'}, {'measure': 'Changes in quality-of-life post-histotripsy, based on EORTC QLQ-C30 scores.', 'timeFrame': '30 days, 3 months, 6 months, 1 year and 2 years post-procedure.', 'description': 'Change of scores based on EORTC QLQ-C30 for liver malignancies from baseline to each of the timepoints specified in the protocol'}, {'measure': 'Changes in quality-of-life post-histotripsy, based on EORTC QLQ-HCC18 scores.', 'timeFrame': '30 days, 3 months, 6 months, 1 year and 2 years post-procedure.', 'description': 'Change of scores based on EORTC QLQ-HCC18 for liver malignancies from baseline to each of the timepoints specified in the protocol'}, {'measure': 'Immune Response Analysis based on Information from Immune Biomarkers.', 'timeFrame': '36 hours, 14 days, 30 days, 3 months and 6 months post-procedure.', 'description': 'Evaluation of changes in circulating immune biomarkers post-histotripsy.'}, {'measure': 'Immune Response Analysis based on Information from Microbiome.', 'timeFrame': '36 hours, 14 days, 30 days, 3 months and 6 months post-procedure.', 'description': 'Evaluation of changes in circulating microbiome post-histotripsy.'}], 'primaryOutcomes': [{'measure': '6-month local control rate.', 'timeFrame': '6 months post-procedure.', 'description': 'Proportion of patients with absence of local tumour progression at the treated site as per RECIST version 1.1 criteria.'}, {'measure': 'Major complication rate.', 'timeFrame': '30 days post-procedure.', 'description': 'Incidence of treatment-related adverse events (AEs) of grade ≥3 (CTCAE v5.0) within 30 days post-procedure.'}], 'secondaryOutcomes': [{'measure': '36-hour technical success rate.', 'timeFrame': '36 hours post-procedure.', 'description': 'Proportion of patients with tumour treated volume ≥ targeted volume with complete tumour coverage, evaluated using contrast-enhanced MRI/CT.'}, {'measure': '30-day technique efficacy rate.', 'timeFrame': '30 days post-procedure.', 'description': 'Proportion of patients with absence of nodular or mass-like enhancement within or along the treatment volume'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Histotripsy', 'Ablation of Liver Tumours'], 'conditions': ['Liver Malignant Tumors']}, 'descriptionModule': {'briefSummary': 'The HALT study aims to evaluate histotripsy in an Asian population for both primary (HCC, CCA) and secondary liver malignancies with liver-limited or oligoprogressive disease. In addition to safety and local control, the study incorporates translational endpoints including immune profiling (PBMCs, cytokines), microbiome shifts, and optional tumour biopsies. This trial will provide critical data on the feasibility, tolerability, and biological impact of histotripsy in a region with the highest burden of liver cancer.', 'detailedDescription': 'This will be a single-arm, multi-centre, prospective pilot study enrolling patients with:\n\nA) Liver limited malignancies (primary or secondary) not eligible for/declined resection or other locoregional treatment modalities.\n\nB) All solid cancer patients (e.g., HCC, colorectal, breast, pancreatic cancers etc) undergoing systemic therapy with oligoprogressive liver disease (defined as ≤ 3 liver limited progressive lesions, ≤ 3 cm in maximum diameter having received \\> 3 months of systemic therapy).\n\nPatients will undergo baseline imaging and laboratory investigations, followed by histotripsy treatment under general anaesthesia. Post-procedure assessments will be performed at predefined intervals for clinical, radiologic, and biomarker evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥21 years at the time of consent.\n2. Histologically/cytologically confirmed cancers (imaging diagnosis as per AASLD allowed for HCC):\n\n A) Liver limited malignancies (primary or secondary) not eligible for/declined resection or other locoregional treatment modalities.\n\n B) All solid cancer patients (e.g., HCC, colorectal, breast, pancreatic cancers etc) undergoing systemic therapy with oligoprogressive liver disease (defined as ≤ 3 liver limited progressive lesions, ≤ 3 cm in maximum diameter having received \\> 3 months of systemic therapy).\n3. Characteristics of hepatic lesions intended for treatment:\n\n * Up to 3 hepatic lesions.\n * Tumour ≤ 3 cm in longest diameter.\n * Lesion(s) must be visible and targetable by ultrasound.\n4. ECOG Performance Status 0-1.\n5. Child-Pugh class A or B7 liver function for patients with underlying cirrhosis.\n6. Adequate hematologic and organ function within 14 days prior to treatment:\n\n * Haemoglobin ≥ 9.0 g/dL\n * Platelets ≥ 75,000/mm³\n * INR ≤ 1.5 × ULN\n * Estimated (by Cockroft-Gault or Modification of Diet in Renal Disease (MDRD) or measured creatinine clearance ≥ 50ml/min.\n * Total bilirubin ≤ 1.5 × upper limit normal or direct bilirubin ≤ ULN for participants with total bilirubin \\> 1.5 × ULN (participants with known history of elevated indirect bilirubin level suggestive of extrahepatic source of elevation e.g. Gilbert's disease may be recruited with bilirubin levels ≤ 3 × ULN)\n * AST and ALT ≤ 5 × ULN\n7. Ability to undergo general anaesthesia, as confirmed by pre-anaesthetic assessment.\n8. Life expectancy ≥ 3 months in the opinion of the investigator.\n9. Willing and able to comply with study visits and procedures.\n10. Written informed consent obtained prior to any study-related procedures.\n\nExclusion Criteria:\n\n1. Extrahepatic disease progression requiring immediate systemic intervention, including new brain metastases or malignant ascites.\n2. Vascular invasion, defined as gross involvement or encasement of major portal vein or hepatic vein branches.\n3. Tumours located adjacent (\\<5 mm) to hollow viscera (e.g., stomach, colon) where histotripsy poses perforation risk.\n4. Lesions poorly visualized on ultrasound or not targetable due to overlying ribs or gas.\n5. Severe or uncontrolled comorbidities including:\n\n * Uncontrolled hypertension or cardiovascular disease\n * Active infection (requiring systemic therapy)\n * Severe chronic obstructive pulmonary disease or hypoxia\n6. Contraindications to general anaesthesia or surgery.\n7. Pregnancy or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days prior to treatment.\n8. Participation in another interventional trial within 4 weeks prior to enrollment, or concurrent participation in a therapeutic study.\n9. Any condition that, in the investigator's judgment, may compromise the patient's safety or interfere with protocol adherence."}, 'identificationModule': {'nctId': 'NCT07428356', 'acronym': 'HALT', 'briefTitle': 'Histotripsy for Ablation of Liver Tumours in Asia', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Centre, Singapore'}, 'officialTitle': 'Histotripsy Ablation for Liver Tumours (HALT): A Multi-centre Prospective Pilot Study on the Safety and Efficacy of Histotripsy in Asian Primary and Secondary Liver Malignancies', 'orgStudyIdInfo': {'id': '2025-0635'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Histotripsy Group', 'description': 'Histotripsy for Ablation of Liver Tumours.', 'interventionNames': ['Device: Histotripsy using HistoSonics Edison™ System']}], 'interventions': [{'name': 'Histotripsy using HistoSonics Edison™ System', 'type': 'DEVICE', 'description': 'The histotripsy procedure will be performed using the HistoSonics Edison™ System, an image-guided, non-invasive focused ultrasound platform specifically designed for mechanical tissue fractionation. Key steps include general anaesthesia and positioning, pre-treatment planning and imaging, and histotripsy ablation procedure.', 'armGroupLabels': ['Histotripsy Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119074', 'city': 'Singapore', 'status': 'NOT_YET_RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Dr Shao-Jin ONG, MBBS, FRCR (UK), FAMS', 'role': 'CONTACT', 'email': 'shao_jin_ong@nuhs.edu.sg'}], 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '168583', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Prof Brian Goh, MBBS, MMed, MSc, FRCSEd, FAMS', 'role': 'CONTACT', 'email': 'brian.goh@singhealth.com.sg', 'phone': '+65 63265440'}], 'facility': 'National Cancer Centre Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '169608', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'A/Prof Chow Wei TOO, MBBS, FRCR, MMed, FAMS', 'role': 'CONTACT', 'email': 'too.chow.wei@singhealth.com.sg'}], 'facility': 'Singapore General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Prof Brian Goh, MBBS, MMed, MSc, FRCSEd, FAMS', 'role': 'CONTACT', 'email': 'brian.goh@singhealth.com.sg', 'phone': '+65 63265440'}, {'name': 'Sandra Hsing', 'role': 'CONTACT', 'email': 'sandra.hsing.san@nccs.com.sg'}], 'overallOfficials': [{'name': 'Prof Brian Goh, MBBS, MMed, MSc, FRCSEd, FAMS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Centre, Singapore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Centre, Singapore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}