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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hepatic arterial infusion chemotherapy + Atezolizumab and bevacizumab | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepatic arterial infusion chemotherapy + Atezolizumab and bevacizumab | Drug | Drug: Oxaliplatin, calcium folinate, 5-FU, Atezolizumab and bevacizumab Procedure: HAIC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute graft rejection rate | defined as the incidence of acute graft rejection after HAIC combined with T+A. | 3 months |
| Objective Response Rate | defined as the treatment response assessed by mRECIST after HAIC combined with T+A treatment | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | defined as the time from HAIC combined with T+A treatment to patient death from any cause. | 1 year |
| Progression-free Survival | defined as the time from the start of HAIC combined with T+A treatment to the onset of tumor Progression or death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hua Li, MD&PhD | Contact | 13060975202 | lihua100@yeah.net | |
| Siqi Li, MD&PhD | Contact | 17827065715 | Celiasiqi@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Shuhong Yi | Third Affiliated Hospital, Sun Yat-Sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Liver Transplantation, the Third Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510630 | China |
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| 1 year |
| Time to Progression | defined as the time from the start of HAIC combined with T+A treatment to tumor progression or death from any cause. | 1 year |
| Serious Adverse Event | The incidence of serious adverse events caused by HAIC combined with T+A treatment. | 1 year |
| Graft Rejection | defined as the incidence of transplant rejection during HAIC combined with T+A treatment. | 1 year |
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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