Combining chemotherapy with immune therapy for liver cancer after transplantation

Hepatic Arterial Infusion Chemotherapy in Combination With Atezolizumab and Bevacizumab for Second-line Treatment of Patients With Recurrent Liver Cancer After Liver Transplantation: an Open-label, Prospective, Single-center, Single-arm Clinical Study Protocol

This study is testing a new treatment that combines chemotherapy with immune therapy to help people with liver cancer that has come back after a liver transplant.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University (Academic / other)
• Drugs / interventions: bevacizumab, Atezolizumab, immunotherapy, chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05833126 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of hepatic arterial infusion chemotherapy combined with Atezolizumab and Bevacizumab for patients experiencing recurrent liver cancer after liver transplantation. The study aims to evaluate the feasibility and therapeutic impact of this combination treatment, particularly focusing on minimizing the risk of organ rejection while effectively targeting tumor growth. Eligible participants will have confirmed hepatocellular carcinoma and will have previously undergone first-line treatment without immunotherapy. The trial seeks to provide a new second-line treatment option for this challenging patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with confirmed recurrent hepatocellular carcinoma post-liver transplantation who have not responded to first-line treatment.

Not a fit: Patients with Child-Pugh grade C liver function or those with tumors suitable for radical treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with recurrent liver cancer after transplantation.

How similar studies have performed: While the combination of these therapies is innovative, similar approaches in other contexts have shown promise, suggesting potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years old, ≤75 years old, gender unlimited;
2. hepatocellular carcinoma confirmed by pathology after liver transplantation;
3. CT and/or MRI confirmed tumor recurrence or metastasis, and the tumor recurrence and metastasis were not suitable for radical treatment such as surgical resection or ablation after multidisciplinary evaluation, and disease progression occurred after one first-line treatment regimen without immunotherapy;
4. There is at least one measurable recurrent or metastatic tumor lesion;
5. The expected survival time is more than 3 months;
6. Child-Pugh grade A and B (≤7 points);
7. Function of other vital organs: absolute neutrophil count ≥1.5×10E9/L; Platelet ≥50×10 e9 / L; Hemoglobin ≥9 g/dL; Serum albumin ≥2.8g/dL; Thyroid stimulating hormone (TSH)≤1 ULN(if TSH is abnormal, both T3 and T4 levels should be checked. If the levels of T3 and T4 were normal, the patients could be enrolled); Bilirubin ≤ 1.5x ULN; ALT and AST≤3 times ULN; Serum creatinine ≤1.5 ULN;
8. ECOG scored 0-2 points;
9. The patient fully understands and voluntarily signs the informed consent, and is willing and able to comply with the requirements of visit, treatment plan, laboratory examination and other requirements of the study schedule.

Exclusion Criteria:

1. Positive expression of PD-L1 in immunohistochemical liver biopsy (parenchymal or non-parenchymal cells of liver);
2. Allergic to bevacizumab and Atezolizumab;
3. ≥ grade II myocardial ischemia or myocardial infarction;
4. The hypertensive drugs cannot be controlled to the normal level (systolic blood pressure \> 140mmHg, diastolic blood pressure \> 90mmHg); Abnormal coagulation function (PT\>16s, APTT\>43s, TT\>21s, Fbg \<2g/L), a history of gastrointestinal bleeding within 6 months;
5. Patients with high risk of bleeding or receiving thrombolytic or anticoagulant treatment;
6. Autoimmune diseases include systemic lupus erythematosus, rheumatoid arthritis, psoriasis, etc.;
7. The primary liver disease of liver transplantation was autoimmune hepatitis, primary biliary cirrhosis, or primary sclerosing cholangitis;
8. interstitial pneumonia and other lung diseases, poor lung function;
9. Participate in clinical trials of other experimental drugs within 4 weeks;
10. infections requiring systemic treatment;
11. human immunodeficiency virus (HIV) positive infection;
12. Other factors that may affect safety or compliance;
13. During treatment of acute rejection or within 1 month after treatment;
14. Poor compliance.

Where this trial is running

Guangzhou, Guangdong

• Department of Liver Transplantation, the Third Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Hua Li, MD&PhD

Conditions Recurrent Liver Cancer After Liver Transplantation; Atezolizumab; Bevacizumab; Hepatic arterial infusion chemotherapy