Clinical trial · Interventional
Bevacizumab Biosimilar Plus FOLFOX4 in the Treatment of Recurrent HCC After Liver Transplantation
An Exploratory Study of Bevacizumab Combined With FOLFOX4 in the Treatment of Recurrent Hepatocellular Carcinoma (HCC) After Liver Transplantation
NCT05355155CI-TRIAL-00058441unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma Recurrent | — | UNRESOLVED | — |
| Post-orthotopic Liver Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab Biosimilar IBI305 | Drug | Bevacizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bevacizumab combine with FOLFOX4
- 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 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.
- interventionNames
- Drug: Bevacizumab Biosimilar IBI305
Primary outcomes (1)
- measure
- Objective Response Rate (ORR) ,Based on RECIST 1.1
- timeFrame
- 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 )
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.