A Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma

Single-arm, Prospective Clinical Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma With High Tumor Load

A Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma (NCT06363825) is a Phase 2 interventional studying Advanced Hepatocellular Carcinoma, sponsored by Fujian Medical University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

To evaluate the efficacy and safety of TAE+HAIC combined with camrelizumab and apatinib in the treatment of advanced liver cancer with high tumor load

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Advanced Hepatocellular Carcinoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 57 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Advanced Hepatocellular Carcinoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 1\. The subjects voluntarily joined the study, had good compliance, cooperated with follow-up, and obtained written willing to sign a consent form; - 2\. Age: 18 years old ≤80 years old, both male and female; - 3\. In accordance with the "Norms for the Diagnosis and Treatment of Primary Liver Cancer (2022 edition)" formulated by the National Health Commission and the 2018 EASL liver Cancer guidelines formulated by the European Association for the Study of Hepatology, a definite diagnosis of hepatocellular carcinoma has been made and pathological results have been obtained; - 4\. There is at least one measurable lesion (spiral CT scan diameter ≥10mm or malignant lymph node short diameter ≥15mm according to RECIST1.1 standard, see Annex 5 for RECIST version 1.1); - 5\. Have not received systematic treatment before; - 6.CNLC was divided into stages Ⅱa-Ⅲb; - 7\. Meet the status of high tumor load, and meet one of the following conditions: 1) High tumor load is defined according to the 7-11 criteria: combined with the number of tumors and the maximum tumor size, high tumor load is defined as and \> 11; 2) Combined with primary branch of portal vein and main cancer thrombus; - 8\. The Child-Pugh classification of liver function is grade A or B (5-8 points); - 9.ECOG PS score 0-1; - 10\. Expected survival ≥12 weeks; - 11\. If the patient has active hepatitis B virus (HBV) infection: if HBV-DNA≤2000, treatment can be started directly; If HBV-DNA \> 2000, start antiviral therapy for one week and then start treatment. - 12\. The major organs function properly and meet the following criteria: 1. The standard of blood routine examination must meet: (no blood transfusion within 14 days) 1. Hemoglobin (HB) ≥100g/L, 2. White blood cell count (WBC)≥3×10\^9/L 3. Absolute neutrophil count (ANC)≥1.5×10\^9/L, 4. Platelet (PLT)≥50×10\^9/L; 2. Biochemical examination shall meet the following standards: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 1\. The subjects voluntarily joined the study, had good compliance, cooperated with follow-up, and obtained written informed consent; * 2\. Age: 18 years old ≤80 years old, both male and female; * 3\. In accordance with the "Norms for the Diagnosis and Treatment of Primary Liver Cancer (2022 edition)" formulated by the National Health Commission and the 2018 EASL liver Cancer guidelines formulated by the European Association for the Study of Hepatology, a definite diagnosis of hepatocellular carcinoma has been made and pathological results have been obtained; * 4\. There is at least one measurable lesion (spiral CT scan diameter ≥10mm or malignant lymph node short diameter ≥15mm according to RECIST1.1 standard, see Annex 5 for RECIST version 1.1); * 5\. Have not received systematic treatment before; * 6.CNLC was divided into stages Ⅱa-Ⅲb; * 7\. Meet the status of high tumor load, and meet one of the following conditions: 1) High tumor load is defined according to the 7-11 criteria: combined with the number of tumors and the maximum tumor size, high tumor load is defined as and \> 11; 2) Combined with primary branch of portal vein and main cancer thrombus; * 8\. The Child-Pugh classification of liver function is grade A or B (5-8 points); * 9.ECOG PS score 0-1; * 10\. Expected survival ≥12 weeks; * 11\. If the patient has active hepatitis B virus (HBV) infection: if HBV-DNA≤2000, treatment can be started directly; If HBV-DNA \> 2000, start antiviral therapy for one week and then start treatment. * 12\. The major organs function properly and meet the following criteria: 1. The standard of blood routine examination must meet: (no blood transfusion within 14 days) 1. Hemoglobin (HB) ≥100g/L, 2. White blood cell count (WBC)≥3×10\^9/L 3. Absolute neutrophil count (ANC)≥1.5×10\^9/L, 4. Platelet (PLT)≥50×10\^9/L; 2. Biochemical examination shall meet the following standards: 1. Bilirubin (BIL)\<1.5 times the upper limit of normal (ULN); 2. Alanine aminotransferase (ALT) and aspartate aminotransferase AST\<5ULN; 3. Serum creatinine (Cr) ≤1.5ULN * 13\. Women of childbearing age must have a negative pregnancy test (serum) or urine HCG test within 7 days prior to admission and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last dose of the test drug; For men, they should be surgically sterilized or consent to an appropriate method of contraception during the trial and for 8 weeks after the last dose of the trial drug. Exclusion Criteria: * 1\. Pregnant or lactating women; * 2\. Patients with autoimmune diseases, organ/hematopoietic stem cell transplantation, or other malignancies (except cured skin basal cell carcinoma and cervical carcinoma in situ); * 3\. Patients with consciousness disorder or inability to cooperate with treatment, combined with mental illness; * 4\. Patients who have participated in other clinical trials in the past three months; * 5\. Received local treatment (such as surgical resection, radiation therapy, ablative therapy, interventional therapy, etc.) within the past 1 month; * 6\. Thrombotic or embolic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism, except portal vein thrombosis, occurred within 6 months prior to the first dose of the study drug; * 7\. Immunosuppressants or systemic hormone therapy (dose \>10mg/ day prednisone or other therapeutic hormones) were used within 14 days before enrollment to achieve immunosuppression; * 8\. Esophageal (fundus) varices rupture and bleeding within 1 month before treatment; * 9\. Uncorrectable coagulation dysfunction and severe blood abnormalities, with a tendency to severe bleeding; Platelet count \< 50×109/L and severe coagulation dysfunction can not withstand surgery (anticoagulant therapy and/or anticoagulant drug use should be stopped more than 1 week before radiotherapy); * 10\. Refractory ascites, bad fluid; * 11\. Active infection, especially inflammation of the biliary system; * 12\. Severe liver, kidney, heart, lung, brain and other major organ failure; * 13\. Previous use of targeted drugs, any component of PD-1 MAB or other similar tests A quick person; * 14\. Patients with hypertension who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg); * 15\. Previous serious cardiovascular disease, including but not limited to the following diseases: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450 ms in men and ≥470 ms in women); According to NYHA criteria, patients with grade Ⅲ to Ⅳ cardiac insufficiency or left ventricular ejection fraction (LVEF) \< 50% indicated by cardiac color ultrasound; * 16\. Patients with positive urinary protein (urinary protein test 2+ or more, or 24-hour urinary protein quantity \> 1.0g); * 17\. Inability to swallow tablets, malabsorption syndrome or any condition affecting gastrointestinal absorption; * 18\. Patients with other concomitant diseases that, in the judgment of the investigator, endanger the patient's safety or interfere with the patient's completion of the study. * 19\. Patients who do not wish to undergo histological examination to confirm the diagnosis.

Treatments Being Tested

DRUG

camrelizumab

TAE: 3-15ml iodized oil; HAIC: Indurating arterial catheter, oxaliplatin 85mg/m\^2 D1, arterial infusion, lasting 1-2 hours (d1), LV 400mg/m\^2, arterial infusion, lasting 2-3 hours (d1), 5-Fu 400mg/m\^2, arterial infusion, lasting 3 hours (d1), and fluorouracil 2400 mg/m\^2 for 24-48h; camrelizumab: 200mg, ivgtt, 30 min (not less than 20 min, not more than 60 min) every 3 weeks (21 days); apatinib mesylate: 250mg, once a day, taken orally (the time of daily administration should be as much as possible), with warm water.Stop for 3 days before next cycle intervention. Camrelizumab was given intravenously 1 day before TAE+HAIC treatment for each cycle, TAE+HAIC treatment was given on the second day, and oral apatinib was started after discharge.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Xinhua Chen

Fuzhou, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06363825), the sponsor (Fujian Medical University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06363825 clinical trial studying?

To evaluate the efficacy and safety of TAE+HAIC combined with camrelizumab and apatinib in the treatment of advanced liver cancer with high tumor load The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06363825?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06363825?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06363825. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06363825. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.