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NCT Number: NCT07587034

HAIC-TACE Plus Apatinib and Camrelizumab for Liver Cancer

To provide evidence-based medical evidence for the optimized combination strategy of local and systemic therapies.

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Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HTAC

Procedure

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.

HAC

Procedure

Patients will receive a combination therapy consisting of HAIC, apatinib, and camrelizumab.

TAC

Procedure

Patients will be treated with a regimen combining TACE, apatinib, and camrelizumab.

Primary outcomes

  1. Progression-Free Survival (PFS) [Assessed by mRECIST Criteria]

    Time frame: 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.

Secondary outcomes

  1. Objective Response Rate (ORR) [Assessed by mRECIST and RECIST Criteria]

    Time frame: 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).

  2. Disease Control Rate (DCR) [Assessed by mRECIST and RECIST Criteria]

    Time frame: 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)

  3. Duration of Response (DoR) [Assessed by RECIST and mRECIST Criteria]

    Time frame: 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.

  4. Overall Survival (OS)

    Time frame: Up to 27 months

    The time from enrollment to death from any cause.

  5. Progression-Free Survival (PFS) [Assessed by RECIST Criteria]

    Time frame: 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.

Other outcomes

  1. Safety Indicators [Including Incidence and Severity of Adverse Events (AE), Serious Adverse Events (SAE), and Abnormal Laboratory Values]

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 14, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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