Hepatic Arterial Infusion Chemotherapy in Combination With Atezolizumab and Bevacizumab for Second-line Treatment of Patients With Recurrent Liver Cancer After Liver Transplantation

NCT ID: NCT05833126

Last Updated: 2023-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-03
• Study Completion Date: 2025-04-01

Brief Summary

For patients with recurrent liver cancer after liver transplantation, the median survival time is low and the prognosis is often poor. On the one hand, it is necessary to take into account the weakened effect of postoperative anti-rejection drugs with the use of immune checkpoint inhibitors, and on the other hand, the therapeutic effect of recurrent tumors should be taken into account. Both HAIC (hepatic arterial infusion chemotherapy) and T+A（Bevacizumab+Atezolizumab) have inhibitory effects on tumor, and we consider combining them organically to explore one that not only has a good inhibitory effect on tumor, but also better reduces the risk and degree of rejection. Therefore, in order to determine the feasibility and effectiveness of hepatic arterial infusion chemotherapy combined with Atezolizumab and Bevacizumab in the second-line treatment of patients with recurrent liver cancer after liver transplantation

Conditions

Recurrent Liver Cancer After Liver Transplantation

Keywords

Atezolizumab; Bevacizumab; Hepatic arterial infusion chemotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hepatic arterial infusion chemotherapy + Atezolizumab and bevacizumab

Hepatic arterial infusion chemotherapy: percutaneous introduction of a standard hepatic arterial catheter through the femoral artery. FOLFOX was sequentially transfused by a fixed catheter. Drugs:FOLFOX regimen: oxaliplatin, calcium folinate, and 5-FU.

Atezolizumab: About 3 to 7 days after HAIC treatment, when liver function is stable (TBILI<2 times the upper limit of normal), Atezolizumab therapy can be started. The dosage was 1200mg and was given intravenously for at least 1 hour, once every 3 weeks. The longest course of treatment is 24 months.

Bevacizumab: About 3 to 7 days after HAIC treatment, when liver function is stable (TBILI<2 times the upper limit of normal), bevacizumab therapy can be started. The dosage was 15mg/kg and was given intravenously for no less than 1 hour, once every 3 weeks. The longest course of treatment is 24 months.

Group Type: EXPERIMENTAL

Hepatic arterial infusion chemotherapy + Atezolizumab and bevacizumab

Intervention Type: DRUG

Drug: Oxaliplatin, calcium folinate, 5-FU, Atezolizumab and bevacizumab Procedure: HAIC

Interventions

Hepatic arterial infusion chemotherapy + Atezolizumab and bevacizumab

Drug: Oxaliplatin, calcium folinate, 5-FU, Atezolizumab and bevacizumab Procedure: HAIC

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shuhong Yi

OTHER

Sponsor Role: lead

Responsible Party

Shuhong Yi

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shuhong Yi

Role: STUDY_DIRECTOR

Third Affiliated Hospital, Sun Yat-Sen University

Locations

Department of Liver Transplantation, the Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hua Li, MD&PhD

Role: CONTACT

Phone: 13060975202

Email: lihua100@yeah.net

Siqi Li, MD&PhD

Role: CONTACT

Phone: 17827065715

Email: Celiasiqi@163.com

Facility Contacts

Jianfeng Zhang, MD

Role: primary

Other Identifiers

[2023]02-116-99

Identifier Type: -

Identifier Source: org_study_id