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This study is a single arm, single center, prospective and open exploratory study.
About 15 patients with recurrent hepatocellular carcinoma (HCC) after liver transplantation are expected to be enrolled.Patients will be treated with bevacizumab and FOLFOX4.Treatment was continued until disease progression, development of intolerable toxicities, death, withdrawal of consent, initiation of new antitumor therapy, whichever occurred first.
Bevacizumab biosimilar：7.5mg/kg，IV，D1，Q2W FOLFOX4：
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab combine with FOLFOX4 | Experimental | Bevacizumab biosimilar：7.5mg/kg，IV，D1，Q2W FOLFOX4：
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab Biosimilar IBI305 | Drug | Patients received bevacizumab and FOLFOX4 every two weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) ,Based on RECIST 1.1 | ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator analysis. Responses (PR or CR) were confirmed no less than 4 weeks after the initial response. CR defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 millimeter [mm] if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the long diameter (LD) (hereafter referred to as sum of LD) of all target lesions, as compared with Baseline summed LD. | From the first dose of study drug to the first date of documentation of disease progression or death whichever occurred first (up to approximately 2 years ) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS), Based on RECIST 1.1 and mRECIST | PFS was defined as the time from the first study dose date to the date of first documentation of disease progression or death (whichever occurred first) based on RECIST 1.1 and mRECIST assessed by investigator review. PD was defined as at least a 20% increase in the sum of LD of target and non-target lesions as compared with the smallest sum of LD and the increase of LD was at least 5 mm (including new lesions). |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yongxiang xia, doctor | Contact | 86-025-68303211 | yx_xia@njmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| xuehao wang | The First Affiliated Hospital with Nanjing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
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| From the first study dose date to the date of first documentation of disease progression or death (whichever occurred first) (up to approximately 2 years ) |
| Disease Control Rate (DCR) ,Based on RECIST 1.1 and mRECIST | the proportion of patients who achieved CR, PR, or SD as their best overall response | Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit(up to approximately 2 years) |
| Duration of Response (DOR) ,Based on RECIST 1.1 and mRECIST | From date of first documented confirmed CR or PR until date of first documentation of PD or death whichever occurred first (up to approximately 2 years) | DOR was defined as the time from the first documentation of CR or PR to the date of first documentation of PD or death (whichever occurred first) in participants with confirmed CR or PR based on RECIST 1.1 and mRECIST assessed by investigator analysis. |
| Overall Survival (OS) | From the date of first dose of study drug until date of death from any cause (up to approximately 2 years ) | From the date of first dose of study drug until date of death from any cause (up to approximately 2 years ) |
| Time-to Response (TTR) Based on RECIST1.1 and mRECIST | TTR was defined as the time from the date of first study dose to the date of first documentation of CR or PR, in participants with confirmed CR or PR. It was evaluated according to RECIST1.1 and mRECIST assessed by investigate. | From date of first dose of study drug until CR or PR (up to approximately 2 years |
| Objective Response Rate (ORR) ,Based on mRECIST | ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) based on mRECIST) assessed by investigator analysis. | From the first dose of study drug to the first date of documentation of disease progression or death whichever occurred first (up to approximately 2 years ) |
| Safety as measured by number and grade of adverse events | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From first dose until 30 days after the last dose (up to approximately 2 years ) |
| ID | Term |
|---|---|
| C410216 | Folfox protocol |
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