Hepatic arterial infusion chemotherapy and immunotherapy for liver cancer

Hepatic Arterial Infusion Chemotherapy and Immunotherapy (HAICI) as Neoadjuvant Treatment for Resectable Hepatocellular Carcinoma in BCLC A/B Stage Beyond Up to Seven Criteria: An Open-Label, Single-Arm, Pilot Study

This study is testing a new way to treat liver cancer by combining chemotherapy and immunotherapy directly into the liver to see if it works better than standard treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhejiang Cancer Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, prednisone, Adebrelimab, doxorubicin
• Locations: 2 sites (Hangzhou, Zhejiang and 1 other locations)
• Trial ID: NCT06741020 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of hepatic arterial infusion chemotherapy combined with immunotherapy for patients with hepatocellular carcinoma (HCC). Participants will undergo a screening process to determine eligibility, followed by a neoadjuvant treatment phase where chemotherapy drugs and immune checkpoint inhibitors are administered directly into the hepatic artery. The study aims to evaluate the safety and efficacy of this localized treatment approach compared to traditional methods. The treatment regimen includes multiple infusions of specific chemotherapy agents and immune therapies over a defined period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a diagnosis of liver cancer that meets specific staging criteria and who have not received prior systemic therapies.

Not a fit: Patients with advanced liver disease or those who have previously undergone systemic chemotherapy or immunotherapy for HCC may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with resectable hepatocellular carcinoma.

How similar studies have performed: Previous studies have shown promising results for hepatic arterial infusion chemotherapy, indicating potential for success with this novel combination approach.

Eligibility criteria

Inclusion Criteria:

1. Aged between 18 and 75 years;
2. Preoperative pathological diagnosis or clinically diagnosed liver cancer meeting EASL/AASLD diagnostic criteria. No prior systemic chemotherapy, immunotherapy, targeted therapy, or other anti-tumor treatments for HCC;
3. Staging in BCLC Stage A or B, and beyond the Up-to-Seven criteria but deemed resectable (negative margins and remaining liver volume sufficient to meet body needs);
4. ECOG performance status score of 0 before the first medication in the study;
5. Liver function classified as Child-Pugh Class A and ICG retention rate at 15 minutes ≤ 10%;
6. Estimated survival time of at least 6 months;
7. Organ function levels meet the requirements and are capable of tolerating surgery before the first medication in the study; Key organ function indicators must meet the following criteria: Hemoglobin ≥ 90 g/L, Neutrophil count ≥ 1.5 × 10⁹/L, Platelet count ≥ 100 × 10⁹/L; Aspartate or Alanine aminotransferase ≤ 5 times the upper limit of normal (ULN), Alkaline phosphatase ≤ 2.5 ULN, Serum albumin ≥ 30 g/L; Serum creatinine \< 1.5 ULN; International Normalized Ratio (INR) ≤ 2 or Prothrombin Time (PT) exceeding the upper limit of normal ≤ 6 seconds; Serum creatinine ≤ 1.5 ULN, Creatinine clearance ≥ 60 mL/min.
8. Male and female participants with reproductive potential must agree to use effective contraception throughout the study period;
9. Sign a consent form agreeing to provide previously stored blood samples, tumor tissue specimens, or fresh biopsy tumor lesions.

Exclusion Criteria:

1. Pathological diagnosis of non-hepatocellular carcinoma;
2. Previous treatment for liver cancer-related chemotherapy, radiotherapy, radiofrequency ablation, interventional therapies and targeted therapy, immunotherapy, or surgical procedures (excluding prior non-tumor-related surgeries or diagnostic biopsies);
3. Preoperative assessment indicates the tumor is unresectable;
4. Viral load limitations: hepatitis B virus (HBV) DNA \> 2000 copies/ml, hepatitis C virus (HCV) RNA \> 1000;
5. Long-term hormone users require ongoing systemic hormone treatment (equivalent to \> 10 mg prednisone/day) or any other form of immunosuppressive therapy;
6. Clinical significant bleeding events or bleeding tendencies within 3 months prior to enrollment or currently receiving thrombolytic or anticoagulant treatment;
7. History of autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, etc.;
8. Active severe clinical infection (\> Grade 2, NCI-CTCAE Version 5.0), including active tuberculosis; history of active tuberculosis infection within the past year without receiving formal anti-tuberculosis treatment or ongoing active tuberculosis; known or suspected active autoimmune diseases;
9. Uncontrolled diabetes (fasting blood glucose ≥ 10 mmol/L), severe lung disease (such as acute lung disease, pulmonary fibrosis affecting lung function, interstitial lung disease. However, resolved radiation pneumonitis is excluded);
10. Clinically significant cardiovascular disease; hypertension that is poorly controlled by antihypertensive medications (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);
11. Recipients of renal replacement therapy;
12. History of other malignancies within the last 5 years. However, cured skin basal cell carcinoma or cervical carcinoma in situ is excluded;
13. Other conditions that are expected to render the participant unable to tolerate surgical treatment;
14. Allergic reactions to any components of the study drug;
15. Presence of alcohol dependence, mental illnesses, pregnancy (or breastfeeding), or other conditions that make participation in clinical trials inappropriate.

Where this trial is running

Hangzhou, Zhejiang and 1 other locations

• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Yuhua Prof. Zhang, M.D.

Conditions Hepatocellular Carcinoma; Neoadjuvant therapy; Beyond up to seven; Hepatic arterial infusion chemotherapy and immunotherapy