An observational study in Hepatocellular Carcinoma, Anti-PD1 Antibody and Liver Diseases, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by Sun Yat-sen University · Observational
For the advanced hepatocellular carcinoma (HCC), the targeted therapy and immunotherapy are recommended. This study focused on the management of Lenvatinib combined anti-PD1 antibody for the HCC. This study will create a database that will provide clinical parameters and outcomes of patients undergoing Lenvatinib and anti-PD1 antibody as part of their standard of care in hopes of answering key clinical questions.
Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma. The programmed cell death protein-1 (PD-1) antibody, was effective and tolerable in patients with hepatocellular carcinoma and portal vein tumor thrombus. We aimed to describe the efficacy and safety of Lenvatinib combined anti-PD1 antibody in patients with hepatocellular carcinoma who can not receive redical therapy.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 600 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
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For the advanced hepatocellular carcinoma (HCC), the targeted therapy and immunotherapy are recommended. This study focused on the management of Lenvatinib combined anti-PD1 antibody for the HCC. This study will create a database that will provide clinical parameters and outcomes of patients undergoing Lenvatinib and anti-PD1 antibody as part of their standard of care in hopes of answering key clinical questions.
Exclusion Criteria:
12 mg (or 8 mg) once daily (QD) oral dosing.
3mg/mg intravenously every 3 weeks
200mg intravenously every 3 weeks
200mg intravenously every 3 weeks
240mg intravenously every 3 weeks
200mg intravenously every 3 weeks
200mg intravenously every 3 weeks
Progression-Free-Survival(PFS)
Progression was defined as progressive disease by independent radiologic review according to mRECIST or death from any cause
Time frame: 24 months
Overall survival (OS)
OS is the length of time from the date of randomization until death from any cause.
Time frame: 24 months
Objective response rate (ORR)
ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all randomized subjects whose best overall response (BOR) is either a CR or PR.
Time frame: 6 months
Disease control rate(DCR)
The proportion of patients who had a best response rating of complete response， partial response, or stable disease.
Time frame: 24 months
Adverse events
Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations pertinent to the safety of the study medication will be recorded on the CRF and included in the final report.
Time frame: 24 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University