HAIC-TACE Plus Apatinib and Camrelizumab for Liver Cancer
ConditionLiver Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Zhongshan Hospital
About this trial
To provide evidence-based medical evidence for the optimized combination strategy of local and systemic therapies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
HTAC
Procedure/SurgeryPatients 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/SurgeryPatients will receive a combination therapy consisting of HAIC, apatinib, and camrelizumab.
TAC
Procedure/SurgeryPatients will be treated with a regimen combining TACE, apatinib, and camrelizumab.
Treatment groups
315 Participants
are divided into 3 treatment groupsGroup A: HTAC GroupExperimental treatment 1 intervention
Group B: HAC GroupExperimental treatment 1 intervention
Group C: TAC GroupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Up to 27 months.Secondary outcomes
1
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).
Time frame
Up to 27 months2
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)
Time frame
Up to 27 months3
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.
Time frame
Up to 27 months4
Overall Survival (OS)
The time from enrollment to death from any cause.
Time frame
Up to 27 monthsOther outcomes
1
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.
Time frame
Up to 27 months.Locations
Sponsors and contacts
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Shanghai Zhongshan Hospital
Lead sponsor
Affiliated Hospital of Nantong University
Collaborator
Nantong First People's Hospital
Collaborator
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
Collaborator
Shandong Public Health Clinical Center
Collaborator
Shanghai Xuhui Hospital
Collaborator
The fifth Hospital Affiliated To WZMU
Collaborator
Source ClinicalTrials.gov
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