HAIC-TACE Plus Apatinib and Camrelizumab for Liver Cancer
16 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
315
Phase
- Phase 2
- La phase 1
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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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Expérimental: 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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Expérimental: TAC Group
Patients will be treated with a regimen combining TACE, apatinib, and camrelizumab.
|
Patients will be treated with a regimen combining TACE, apatinib, and camrelizumab.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Progression-Free Survival (PFS) [Assessed by mRECIST Criteria]
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall Survival (OS)
Délai: 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]
Délai: 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
|
|
Disease Control Rate (DCR) [Assessed by mRECIST and RECIST Criteria]
Délai: 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]
Délai: 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
|
|
Progression-Free Survival (PFS) [Assessed by RECIST Criteria]
Délai: 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.
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Safety Indicators [Including Incidence and Severity of Adverse Events (AE), Serious Adverse Events (SAE), and Abnormal Laboratory Values]
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juin 2026
Achèvement primaire (Estimé)
1 décembre 2029
Achèvement de l'étude (Estimé)
1 décembre 2029
Dates d'inscription aux études
Première soumission
8 mai 2026
Première soumission répondant aux critères de contrôle qualité
8 mai 2026
Première publication (Réel)
14 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MATCH-001
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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