Status:
UNKNOWN
Bevacizumab Biosimilar Plus FOLFOX4 in the Treatment of Recurrent HCC After Liver Transplantation
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Post-orthotopic Liver Transplantation
Hepatocellular Carcinoma Recurrent
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 enrol...
Detailed Description
Bevacizumab biosimilar：7.5mg/kg，IV，D1，Q2W FOLFOX4： 1. Oxaliplatin: 85 mg/m2 , IV, D1，Q2W 2. Calcium leovorin: 200 mg/m2 ,IV, D1、D2，Q2W 3. Fluorouracil: 400 mg/m2 push infusion and given 600mg/m2 intr...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- adult patients with hepatocellular carcinoma who have received liver transplantation have postoperative radiographic or pathological evidence of recurrence;
- have not received the first line of standard treatment or have received the first line of standard treatment failure;
- at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 2;
- Child-Pugh class A or B (Child-Pugh score ≤7 );
- adequate organ function;
- a predicted life expectancy of at least 3 months.
- 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;
- esophageal or gastric variceal bleeding with portal hypertension within the past 6 months.
Exclusion
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05355155
Start Date
May 1 2022
End Date
December 31 2024
Last Update
May 11 2022
Active Locations (1)
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1
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029