MATCH-001: A Multicenter, Open-Label, Randomized Controlled Trial of Hepatic Arterial Infusion Chemotherapy Followed by Transarterial Chemoembolization Combined With Apatinib and Camrelizumab in Patients With Intermediate and Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 315
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
To provide evidence-based medical evidence for the optimized combination strategy of local and systemic therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
This study adopts a single-blind design, where subjects and staff responsible for subject recruitment and management are aware of the study group assignments and arrange corresponding screening interventions, while physicians conducting clinical examinations for subjects are unaware of the subjects' group allocations.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years.
- •Diagnosed with hepatocellular carcinoma (HCC) in accordance with the Standardization for Diagnosis and Treatment of Primary Hepatic Carcinoma (2024 Edition) issued by the National Health Commission of the People's Republic of China.
- •BCLC stage B or C, with no indication or refusal of surgical treatment, and measurable lesions meeting the mRECIST (Modified Response Evaluation Criteria in Solid Tumors) criteria on baseline imaging.
- •Child-Pugh liver function grade A or well-compensated grade B (score ≤7).
- •ECOG Performance Status (PS) score 0-
- •Expected survival time ≥12 weeks.
排除标准
- •Prior transarterial chemoembolization (TACE) or other local therapies for HCC (except bridging liver transplantation).
- •Active viral hepatitis (hepatitis B or C) with pre-treatment viral load >100 IU/mL (positive for HCV RNA or HBV DNA) or without consistent antiviral therapy.
- •Alcohol abuse or pregnancy.
- •Concurrent other malignancies or history of other malignancies within the past 3 years.
- •Renal dysfunction (creatinine [Cr] >2 mg/dL or creatinine clearance [CCr] <30 mL/min) or severe organic diseases of vital organs (heart, lung, brain, etc.).
- •Inability to cooperate with interventional procedures.
- •Presence of distant metastasis.
- •Main portal vein tumor thrombus accompanied by impaired portal venous blood flow and collateral circulation.
- •Withdrawal Criteria
- •Identification of non-compliance with the study protocol during the trial.
- •Administration of radiotherapy or other interventions during the trial that prevent efficacy evaluation.
- •Discontinuation of treatment due to severe adverse reactions (excluded from efficacy analysis but included in adverse reaction statistics).
- •Patient or representative withdraws informed consent or requests to stop treatment.
- •Loss to follow-up or death of the patient.
- •Key Terminology Notes
- •National Health Commission of the People's Republic of China: Official English name of the Chinese health authority, consistent with government documentation.
- •Standardization for Diagnosis and Treatment of Primary Hepatic Carcinoma (2024 Edition) : Translated title of the 2024 national guideline for HCC diagnosis and treatment, aligning with the 2022 edition's official English translation published in Cancer Research on Prevention and Treatment.
- •mRECIST: Abbreviation for Modified Response Evaluation Criteria in Solid Tumors, the standard for assessing treatment response in HCC, widely used in clinical trials.
- •BCLC Staging: Barcelona Clinic Liver Cancer staging system, a globally recognized framework for HCC prognosis and treatment decision-making.
- •Child-Pugh Score: A widely used tool to assess liver function in patients with cirrhosis, with grades A (5-6 points), B (7-9 points), and C (10-15 points).
- •ECOG PS Score: Eastern Cooperative Oncology Group Performance Status, a scale from 0 (fully active) to 5 (dead) used to evaluate a patient's ability to perform daily activities.
研究组 & 干预措施
TAC Group
Patients will be treated with a regimen combining TACE, apatinib, and camrelizumab.
干预措施: TAC (Procedure)
HAC Group
Patients will receive a combination therapy consisting of HAIC, apatinib, and camrelizumab.
干预措施: HAC (Procedure)
HTAC Group
Patients will first undergo hepatic arterial infusion chemotherapy (HAIC) treatment. Subsequently, transarterial chemoembolization (TACE) will be administered sequentially following the completion of HAIC. This regimen will be combined with apatinib (a vascular endothelial growth factor receptor 2 [VEGFR-2] inhibitor) and camrelizumab (a programmed cell death protein 1 [PD-1] inhibitor) therapy.
干预措施: HTAC (Procedure)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to 27 months.
Definition: The time from enrollment to tumor progression or death from any cause. Assessment: Evaluated and judged by the investigator based on the mRECIST criteria.
次要结局
- Objective Response Rate (ORR)(Up to 27 months)
- Disease Control Rate (DCR)(Up to 27 months)
- Duration of Response (DoR)(Up to 27 months)
- Overall Survival (OS)(Up to 27 months)
- Progression-Free Survival (PFS) - Based on RECICL Criteria(Up to 27 months.)