Liver Cancer
Conditions
Brief summary
To provide evidence-based medical evidence for the optimized combination strategy of local and systemic therapies.
Interventions
PROCEDUREHTAC
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.
PROCEDUREHAC
Patients will receive a combination therapy consisting of HAIC, apatinib, and camrelizumab.
PROCEDURETAC
Patients will be treated with a regimen combining TACE, apatinib, and camrelizumab.
Sponsors
Shanghai Zhongshan Hospital
Affiliated Hospital of Nantong University
Nantong First People's Hospital
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 design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) [Assessed by mRECIST Criteria] | 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
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) [Assessed by mRECIST and RECIST Criteria] | 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). |
| Disease Control Rate (DCR) [Assessed by mRECIST and RECIST Criteria] | 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) |
| Duration of Response (DoR) [Assessed by RECIST and mRECIST Criteria] | 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. |
| Overall Survival (OS) | Up to 27 months | The time from enrollment to death from any cause. |
| Progression-Free Survival (PFS) [Assessed by RECIST Criteria] | 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. |
Outcome results
None listed