Not yet recruiting NCT07587034
HAIC-TACE Plus Apatinib and Camrelizumab for Liver Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HTAC, HAC, TAC.
- Who it may be relevant to
- Registry conditions: Liver Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
To provide evidence-based medical evidence for the optimized combination strategy of local and systemic therapies.
Interventions
- 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. - Procedure HAC
Patients will receive a combination therapy consisting of HAIC, apatinib, and camrelizumab. - Procedure TAC
Patients will be treated with a regimen combining TACE, apatinib, and camrelizumab.
Primary outcome measures
- Progression-Free Survival (PFS) [Assessed by mRECIST Criteria] [Time frame: Up to 27 months.]
Secondary outcome measures (5)
- Objective Response Rate (ORR) [Assessed by mRECIST and RECIST Criteria] [Time frame: Up to 27 months]
- Disease Control Rate (DCR) [Assessed by mRECIST and RECIST Criteria] [Time frame: Up to 27 months]
- Duration of Response (DoR) [Assessed by RECIST and mRECIST Criteria] [Time frame: Up to 27 months]
- Overall Survival (OS) [Time frame: Up to 27 months]
- Progression-Free Survival (PFS) [Assessed by RECIST Criteria] [Time frame: Up to 27 months.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07587034 · MATCH-001