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HAIC-TACE Plus Apatinib and Camrelizumab for Liver Cancer

16 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

315

Fase

  • Fase 2
  • Fase 1

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria

  1. Age 18-80 years.
  2. 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.
  3. 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.
  4. Child-Pugh liver function grade A or well-compensated grade B (score ≤7).
  5. ECOG Performance Status (PS) score 0-1.
  6. Expected survival time ≥12 weeks.

Exclusion Criteria

  1. Prior transarterial chemoembolization (TACE) or other local therapies for HCC (except bridging liver transplantation).
  2. 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.
  3. Alcohol abuse or pregnancy.
  4. Concurrent other malignancies or history of other malignancies within the past 3 years.
  5. 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.).
  6. Inability to cooperate with interventional procedures.
  7. Presence of distant metastasis.
  8. Main portal vein tumor thrombus accompanied by impaired portal venous blood flow and collateral circulation.

Withdrawal Criteria

  1. Identification of non-compliance with the study protocol during the trial.
  2. Administration of radiotherapy or other interventions during the trial that prevent efficacy evaluation.
  3. Discontinuation of treatment due to severe adverse reactions (excluded from efficacy analysis but included in adverse reaction statistics).
  4. Patient or representative withdraws informed consent or requests to stop treatment.
  5. 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Procedure: HTAC
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.
Experimenteel: HAC Group
Patients will receive a combination therapy consisting of HAIC, apatinib, and camrelizumab.
Procedure: HAC
Patients will receive a combination therapy consisting of HAIC, apatinib, and camrelizumab.
Experimenteel: TAC Group
Patients will be treated with a regimen combining TACE, apatinib, and camrelizumab.
Procedure: TAC
Patients will be treated with a regimen combining TACE, apatinib, and camrelizumab.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression-Free Survival (PFS) [Assessed by mRECIST Criteria]
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Survival (OS)
Tijdsspanne: 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]
Tijdsspanne: 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]
Tijdsspanne: 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
Duration of Response (DoR) [Assessed by RECIST and mRECIST Criteria]
Tijdsspanne: 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]
Tijdsspanne: 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.

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Safety Indicators [Including Incidence and Severity of Adverse Events (AE), Serious Adverse Events (SAE), and Abnormal Laboratory Values]
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Shanghai Zhongshan Hospital

Medewerkers

Nantong First People's Hospital
Affiliated Hospital of Nantong University
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
Shandong Public Health Clinical Center
Shanghai Xuhui Hospital
The fifth Hospital Affiliated To WZMU

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 december 2029

Studie voltooiing (Geschat)

1 december 2029

Studieregistratiedata

Eerst ingediend

8 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

8 mei 2026

Eerst geplaatst (Werkelijk)

14 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

16 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • MATCH-001

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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