An Exploratory Study of Bevacizumab Combined With FOLFOX4 in the Treatment of Recurrent Hepatocellular Carcinoma (HCC) After Liver Transplantation
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Objective Response Rate (ORR) ,Based on RECIST 1.1
Overview
Brief Summary
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.
Detailed Description
Bevacizumab biosimilar：7.5mg/kg，IV，D1，Q2W FOLFOX4：
- Oxaliplatin: 85 mg/m2 , IV, D1，Q2W
- Calcium leovorin: 200 mg/m2 ,IV, D1、D2，Q2W
- Fluorouracil: 400 mg/m2 push infusion and given 600mg/m2 intravenously 22 hours later， D1、D2, Q2W
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •allergy to the study drugs or their expedients or severe allergy to other monoclonal antibodies;
- •receipt of attenuated inactivated vaccines within 4 weeks of the start of the study or scheduled for such vaccination during the study;
- •evident concern of GI bleeding (local active ulcer, Guaic test at least ++) or a history of GI bleeding within the preceding 6 months;
- •uncontrolled pleural or peritoneal effusion;
- •pulmonary tuberculosis, sarcoidosis, HIV infection, or active HBV or HCV infection;
- •uncontrolled cardiac arrhythmia (including QTC interval ≥500 ms);
- •hepatic encephalopathy;
- •Known hepatocholangiocarcinoma, mixed hepatocellular and cholangiocellular carcinoma, fibrolamellar carcinoma, or a history of or concurrent cancer except cervical carcinoma in situ and cured basal cell carcinoma;
- •pregnant or lactating women or women contemplating pregnancy;
- •severe concomitant illness that jeopardizes patient safety or interferes with the completion of the study as deemed by the investigators;
Arms & Interventions
Bevacizumab combine with FOLFOX4
Bevacizumab biosimilar：7.5mg/kg，IV，D1，Q2W FOLFOX4：
- Oxaliplatin: 85 mg/m2 , IV, D1，Q2W
- Calcium leovorin: 200 mg/m2 ,IV, D1、D2，Q2W
- Fluorouracil: 400 mg/m2 push infusion and given 600mg/m2 intravenously 22 hours later， D1、D2, Q2W Treatment will continue until disease progression, an unacceptable toxicity, or the patient voluntarily discontinues the study, whichever comes first.
Intervention: Bevacizumab Biosimilar IBI305 (Drug)
Outcomes
Primary Outcomes
Objective Response Rate (ORR) ,Based on RECIST 1.1
Time Frame: 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 )
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.
Secondary Outcomes
- Overall Survival (OS)(From the date of first dose of study drug until date of death from any cause (up to approximately 2 years ))
- Objective Response Rate (ORR) ,Based on mRECIST(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 ))
- Progression-free Survival (PFS), Based on RECIST 1.1 and mRECIST(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(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))
- Time-to Response (TTR) Based on RECIST1.1 and mRECIST(From date of first dose of study drug until CR or PR (up to approximately 2 years)
- Safety as measured by number and grade of adverse events(From first dose until 30 days after the last dose (up to approximately 2 years ))
- Duration of Response (DOR) ,Based on RECIST 1.1 and mRECIST(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.)
Investigators
Xuehao Wang
Head of Hepatobiliary Center；Academician of Chinese Academy of Engineering
The First Affiliated Hospital with Nanjing Medical University