HAIC-TACE Plus Apatinib and Camrelizumab for Liver Cancer
2026年5月16日 更新者：Shanghai Zhongshan Hospital
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
To provide evidence-based medical evidence for the optimized combination strategy of local and systemic therapies.
調査の概要
研究の種類
介入
入学 (推定)
315
段階
- フェーズ2
- フェーズ 1
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria
- 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 0-1.
- Expected survival time ≥12 weeks.
Exclusion Criteria
- 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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
|
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.
|
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実験的：HAC Group
Patients will receive a combination therapy consisting of HAIC, apatinib, and camrelizumab.
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Patients will receive a combination therapy consisting of HAIC, apatinib, and camrelizumab.
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実験的：TAC Group
Patients will be treated with a regimen combining TACE, apatinib, and camrelizumab.
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Patients will be treated with a regimen combining TACE, apatinib, and camrelizumab.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Progression-Free Survival (PFS) [Assessed by mRECIST Criteria]
時間枠：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. |
Up to 27 months.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall Survival (OS)
時間枠：Up to 27 months
|
The time from enrollment to death from any cause.
|
Up to 27 months
|
|
Objective Response Rate (ORR) [Assessed by mRECIST and RECIST Criteria]
時間枠：Up to 27 months
|
The proportion of patients with objective tumor response, as evaluated by the investigator using both mRECIST and RECICL criteria, including cases of complete response (CR) and partial response (PR).
|
Up to 27 months
|
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Disease Control Rate (DCR) [Assessed by mRECIST and RECIST Criteria]
時間枠：Up to 27 months
|
The proportion of patients with controlled tumor disease, as evaluated by the investigator using both mRECIST and RECICL criteria, including cases of complete response (CR), partial response (PR), and stable disease (SD) (lasting for more than 4 weeks)
|
Up to 27 months
|
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Duration of Response (DoR) [Assessed by RECIST and mRECIST Criteria]
時間枠：Up to 27 months
|
Definition: The time from the first assessment of complete response (CR) or partial response (PR) to the first assessment of progressive disease (PD) or death from any cause. Assessment: Evaluated and judged by the investigator based on both RECICL and mRECIST criteria. |
Up to 27 months
|
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Progression-Free Survival (PFS) [Assessed by RECIST Criteria]
時間枠：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 RECICL criteria. |
Up to 27 months.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Safety Indicators [Including Incidence and Severity of Adverse Events (AE), Serious Adverse Events (SAE), and Abnormal Laboratory Values]
時間枠：Up to 27 months.
|
Evaluation Standard: Judged in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.
|
Up to 27 months.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2029年12月1日
研究の完了 (推定)
2029年12月1日
試験登録日
最初に提出
2026年5月8日
QC基準を満たした最初の提出物
2026年5月8日
最初の投稿 (実際)
2026年5月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月20日
QC基準を満たした最後の更新が送信されました
2026年5月16日
最終確認日
2026年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。