HAIC-TACE Plus Apatinib and Camrelizumab for Liver Cancer

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Cancer
• Intervention / Treatment: Procedure: HTAC; Procedure: HAC; Procedure: TAC

• Study Type: Interventional
• Enrollment (Estimated): 315
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.
Experimental: 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.
Experimental: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) [Assessed by mRECIST Criteria]	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	The time from enrollment to death from any cause.	Up to 27 months
Objective Response Rate (ORR) [Assessed by mRECIST and RECIST Criteria]	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]	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]	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]	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Indicators [Including Incidence and Severity of Adverse Events (AE), Serious Adverse Events (SAE), and Abnormal Laboratory Values]	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.

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 16, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: MATCH-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No