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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- 6-month local control rate.
研究概览
简要总结
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.
详细描述
This will be a single-arm, multi-centre, prospective pilot study enrolling patients with:
A) Liver limited malignancies (primary or secondary) not eligible for/declined resection or other locoregional treatment modalities.
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).
Patients 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Patients will undergo baseline imaging and laboratory investigations, followed by histotripsy treatment under general anaesthesia.
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥21 years at the time of consent.
- •Histologically/cytologically confirmed cancers (imaging diagnosis as per AASLD allowed for HCC):
- •A) Liver limited malignancies (primary or secondary) not eligible for/declined resection or other locoregional treatment modalities.
- •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).
- •Characteristics of hepatic lesions intended for treatment:
- •Up to 3 hepatic lesions.
- •Tumour ≤ 3 cm in longest diameter.
- •Lesion(s) must be visible and targetable by ultrasound.
- •ECOG Performance Status 0-
- •Child-Pugh class A or B7 liver function for patients with underlying cirrhosis.
- •Adequate hematologic and organ function within 14 days prior to treatment:
- •Haemoglobin ≥ 9.0 g/dL
- •Platelets ≥ 75,000/mm³
- •INR ≤ 1.5 × ULN
- •Estimated (by Cockroft-Gault or Modification of Diet in Renal Disease (MDRD) or measured creatinine clearance ≥ 50ml/min.
- •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)
- •AST and ALT ≤ 5 × ULN
- •Ability to undergo general anaesthesia, as confirmed by pre-anaesthetic assessment.
- •Life expectancy ≥ 3 months in the opinion of the investigator.
- •Willing and able to comply with study visits and procedures.
- •Written informed consent obtained prior to any study-related procedures.
排除标准
- •Extrahepatic disease progression requiring immediate systemic intervention, including new brain metastases or malignant ascites.
- •Vascular invasion, defined as gross involvement or encasement of major portal vein or hepatic vein branches.
- •Tumours located adjacent (<5 mm) to hollow viscera (e.g., stomach, colon) where histotripsy poses perforation risk.
- •Lesions poorly visualized on ultrasound or not targetable due to overlying ribs or gas.
- •Severe or uncontrolled comorbidities including:
- •Uncontrolled hypertension or cardiovascular disease
- •Active infection (requiring systemic therapy)
- •Severe chronic obstructive pulmonary disease or hypoxia
- •Contraindications to general anaesthesia or surgery.
- •Pregnancy or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days prior to treatment.
- •Participation in another interventional trial within 4 weeks prior to enrollment, or concurrent participation in a therapeutic study.
- •Any condition that, in the investigator's judgment, may compromise the patient's safety or interfere with protocol adherence.
研究组 & 干预措施
Histotripsy Group
Histotripsy for Ablation of Liver Tumours.
干预措施: Histotripsy using HistoSonics Edison™ System (Device)
结局指标
主要结局
6-month local control rate.
时间窗: 6 months post-procedure.
Proportion of patients with absence of local tumour progression at the treated site as per RECIST version 1.1 criteria.
Major complication rate.
时间窗: 30 days post-procedure.
Incidence of treatment-related adverse events (AEs) of grade ≥3 (CTCAE v5.0) within 30 days post-procedure.
次要结局
- 36-hour technical success rate.(36 hours post-procedure.)
- 30-day technique efficacy rate.(30 days post-procedure.)