HAIC-TACE Plus Apatinib and Camrelizumab for Liver Cancer

NCT07587034 | Not Yet Recruiting Phase 1

• 1 other identifier: MATCH-001
• Study Type: interventional
• Target: 315
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  Up to 27 months

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

  Up to 27 months

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

  Up to 27 months

• Overall Survival (OS)

  Up to 27 months

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

  Up to 27 months.

Other Outcomes (1)

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

  Up to 27 months.

Study Arms (3)

HTAC Group

EXPERIMENTAL

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

HAC Group

EXPERIMENTAL

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

Procedure: HAC

TAC Group

EXPERIMENTAL

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

Procedure: TAC

Interventions

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.

HTAC Group

HAC PROCEDURE

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

HAC Group

TAC PROCEDURE

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

TAC Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: This study adopts a single-blind design, where subjects and staff responsible for subject recruitment and management are aware of the study group assignments and arrange corresponding screening interventions, while physicians conducting clinical examinations for subjects are unaware of the subjects' group allocations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 20, 2026

Record last verified: 2026-05