Comparing two treatments for advanced liver cancer

Drug-eluting Bead Transarterial Chemoembolization and Drug-eluting Bead Transarterial Chemoembolization Sequential Hepatic Artery Chemotherapy Infusion for Unresectable BCLC Stage C HCC: A Randomized Controlled Trial

This study is testing two different treatment methods for people with advanced liver cancer to see which one works better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Zhengzhou University (Academic / other)
• Drugs / interventions: Lenfacitinib, Apatinib, chemotherapy, immunotherapy
• Locations: 16 sites (Luohe, Henan and 15 other locations)
• Trial ID: NCT05788835 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of two treatment approaches for patients with unresectable BCLC stage C hepatocellular carcinoma (HCC): drug-eluting bead transarterial chemoembolization (DEB-TACE) and DEB-TACE followed by sequential hepatic arterial infusion chemotherapy (HAIC). The study will involve patients who meet specific diagnostic criteria and have measurable lesions, assessing their response to the treatments over time. The trial is designed to provide insights into which method may offer better outcomes for this challenging stage of liver cancer.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with unresectable BCLC stage C HCC and measurable tumor lesions.

Not a fit: Patients with severe comorbidities or those with Child-Pugh class C liver disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients with advanced liver cancer.

How similar studies have performed: While DEB-TACE has shown promise in treating liver cancer, the sequential use of HAIC in this context is a novel approach that has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Patient with unresectable HCC who strictly meet the clinical diagnostic criteria of the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) or who have been confirmed by histopathology or cytology, There was at least one measurable lesion (according to the requirements of mRECIST 1.1, the spiral CT scan diameter of the measurable lesion was ≥10mm or the short diameter of enlarged lymph node was ≥15mm).
2. The sum of the diameter of single or 2-3 tumors ≥5cm. Tumor stage: Stage C of BCLC.
3. Patient age between 18 and 75，male or female.
4. ECOG 0-1.
5. Expected life span ≥ 3 months.
6. No history of severe comorbidities, such as hypertension, coronary heart disease, and mental illness, and no history of severe allergies.
7. Child-Pugh A-B.
8. HBV DNA\<2000 IU/ml.
9. Women of childbearing age must undergo a pregnancy test within 7 days prior to enrollment.
10. Patients sign informed consent, good compliance, cooperate with treatment.

Exclusion Criteria:

1. Imaging examinations were conducted for HCC patients with large liver tumors (≥60% of liver volume), or carcinoma thrombus in main portal vein (occupying ≥50% of vascular diameter), or carcinoma thrombus invading mesenteric vein or inferior vena cava, or significant arteriovenous/venous fistula.
2. Before participating in this study, she had received local treatment such as TACE, external radiotherapy and radioactive particle implantation, and had undergone systemic chemotherapy, oral liver cancer targeting drugs (Sorafenib, Lenfacitinib, Apatinib) and immunotherapy such as PD-1/PD-L1/CDLA-4.
3. Diffuse liver cancer patients.
4. Patients with grade Ⅱ or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450ms for men and 470ms for women.
5. A history of gastrointestinal bleeding within the past 6 months or a definite tendency to gastrointestinal bleeding.
6. Abnormal clotting function, bleeding tendency or receiving thrombolytic or anticoagulant therapy.
7. Patients with central nervous system metastases or known brain metastases. Co-infected patients with HIV; Pregnant or lactating patients. Patients preparing for liver transplantation (other than those with previous liver transplantation.
8. Systemic failure, estimated survival time \<3 months.
9. Severe renal dysfunction.
10. The patients could not complete the treatment plan due to various reasons, and lost control within three months after enrollment.

Where this trial is running

Luohe, Henan and 15 other locations

• Luo He Central Hospital — Luohe, Henan, China (Recruiting)
• Luo Yang Central Hospital — Luoyang, Henan, China (Recruiting)
• Deng zhou People's Hospital — Nanyang, Henan, China (Recruiting)
• Nan Yang Central Hospital — Nanyang, Henan, China (Recruiting)
• General Hospital of Pingmei Shenma Group — Pingdingshan, Henan, China (Recruiting)
• First People's Hospital of Shangqiu — Shangqiu, Henan, China (Recruiting)
• Shangqiu Municipal Hospital — Shangqiu, Henan, China (Recruiting)
• Xin Yang Central Hospital — Xinyang, Henan, China (Recruiting)
• The Fifth Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
• Zhengzhou Central Hospital — Zhengzhou, Henan, China (Recruiting)
• Zhou Kou Central Hospital — Zhoukou, Henan, China (Recruiting)
• First People's Hospital of Zhu Madian — Zhumadian, Henan, China (Recruiting)
• Zhu Ma Dian Central Hospital — Zhumadian, Henan, China (Recruiting)
• Zhu Madian Traditional Chinese Medicine Hospital — Zhumadian, Henan, China (Recruiting)
• Second People's Hospital of Jiaozuo — Jiaozuo, China (Recruiting)

Study contacts

• Principal investigator: Xuhua Xuhua, Ph.D. — The First Affiliated Hospital of Zhengzhou University
• Study coordinator: Xuhua Duan, Ph.D.

Conditions HCC; DEB-TACE- HAIC; DEB-TACE