NCT07206511尚未招募不适用
Clinical Outcomes of Initially Unresectable Hepatocellular Carcinoma Patients Receiving TACE/HAIC Plus Anti-Angiogenic Agents and Immune Checkpoint Inhibitors as Conversion Therapy, Achieving Complete Radiological Response or Resectability, Followed by Systemic Treatment or Surgical Resection: A Prospective Cohort Study
Shanghai Zhongshan Hospital0 个研究点目标入组 278 人开始时间: 2025年10月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 278
- 主要终点
- Event-Free Survival (EFS)
研究概览
简要总结
This is a prospective cohort study designed to evaluate the effectiveness and safety of two post-conversion treatment strategies for patients with initially unresectable hepatocellular carcinoma (uHCC). Participants first receive conversion therapy with transarterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) combined with anti-angiogenic agents and immune checkpoint inhibitors (ICIs). After this therapy, patients who achieve complete radiological response (rCR) or meet resectability criteria will either undergo surgical resection or continue systemic therapy. The study aims to compare outcomes between these two strategies to help guide treatment decisions for advanced liver cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent.
- •Age 18-75 years.
- •Hepatocellular carcinoma (HCC) confirmed by histology/cytology or diagnosed according to the AASLD criteria.
- •Initially unresectable HCC (uHCC), defined according to the Chinese Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 edition) and the Chinese Expert Consensus on Conversion and Perioperative Therapy for Primary Liver Cancer (2024 edition): HCC considered unsafe for curative resection due to inability to ensure both oncological completeness (R0 resection) and functional hepatic reserve (adequate future liver remnant with good vascular supply and biliary drainage to maintain postoperative liver function and minimize morbidity and mortality). Mainly includes CNLC stage Ib-IIIa or potentially resectable cases. Some stage Ia patients may also be considered uHCC if the tumor is adjacent to major intrahepatic vessels or involves the first/second hepatic hilum making R0 resection infeasible, or if severe cirrhosis increases risk of postoperative liver failure and complications; these can be considered after successful conversion and supportive treatment.
- •No prior systemic therapy before conversion treatment.
- •Conversion therapy regimen must include TACE or HAIC plus anti-angiogenic agents and immune checkpoint inhibitors (ICIs).
- •Anti-angiogenic agents may include lenvatinib, sorafenib, apatinib, donafenib, anlotinib, bevacizumab.
- •ICIs may include pembrolizumab, atezolizumab, nivolumab, sintilimab, tislelizumab, toripalimab, penpulimab, cadonilimab, KN-
- •After conversion therapy, hepatic lesions achieve radiological complete response (rCR) by mRECIST criteria on contrast-enhanced CT or MRI, or are assessed to have reached resectability criteria (eligible for curative hepatectomy or downstaging enabling safe surgery).
- •After achieving rCR or resectability, patients must have received either liver resection or continued systemic therapy with scheduled follow-up.
- •Child-Pugh class A or B liver function.
- •Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1.
排除标准
- •Presence of another primary malignancy in other organs.
- •History of other malignancies.
- •Recurrent HCC occurring <2 years after previous curative surgery or adjuvant therapy.
- •Received treatments other than TACE or HAIC plus anti-angiogenic agents and ICIs during the conversion phase.
- •Received treatments during postoperative or maintenance systemic therapy that differ from the initial conversion regimen.
- •Severe organ dysfunction.
- •Incomplete radiological assessment data after treatment.
- •Child-Pugh class C liver function.
- •Pregnant or breastfeeding women.
- •Patients undergoing only functional future liver remnant (FLR) hypertrophy procedures (e.g., ALPPS or PVE) for insufficient FLR without other criteria for uHCC conversion.
结局指标
主要结局
Event-Free Survival (EFS)
时间窗: From initiation of post-conversion therapy to the first documented event (recurrence, progression, or death), up to 36 months
Defined as the time from the date of achieving rCR or resectability criteria to the time of becoming inoperable, recurrence, progression, or death from any cause for uHCC patients.
次要结局
- 2-Year Event-Free Survival (EFS) Rate(2 years after initiation of post-conversion therapy)
- Overall Survival (OS)(Up to 36 months after initiation of post-conversion therapy)
- Treatment Safety(From initiation of post-conversion therapy through 30 days after last treatment or surgery, up to 36 months follow-up)
- Cost-Effectiveness of Post-Conversion Treatment Strategies(Up to 36 months after initiation of post-conversion therapy)
研究者
Jian Zhou
Hospital President
Shanghai Zhongshan Hospital
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