Hepatic Arterial Infusion Chemotherapy and Immunotherapy for Hepatocellular Carcinoma

Launched by ZHEJIANG CANCER HOSPITAL · Dec 17, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for liver cancer, specifically hepatocellular carcinoma (HCC). Researchers are testing a method called hepatic artery infusion chemotherapy, which delivers chemotherapy directly to the liver, combined with an immune therapy using PD-L1 monoclonal antibodies. This treatment aims to more effectively target and kill cancer cells while enhancing the body’s immune response to the disease. The trial is currently looking for participants aged 18 to 75 who have been diagnosed with liver cancer that is still operable but exceeds certain size and quantity limits for surgery. Key criteria for eligibility include having good overall health and liver function, as well as no prior treatments for liver cancer.

If you join this study, you can expect to receive this innovative treatment and be closely monitored by medical professionals throughout the process. Participation also involves giving consent for the use of some of your medical samples, like blood and tissue, to help researchers understand how well the treatment works. It's important to discuss any questions or concerns with the research team before deciding to participate. This trial could potentially offer new hope for patients with liver cancer who are looking for effective treatment options.

Gender

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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.