A Phase 2 interventional study of Lenvatinib, Tislelizumab Combined with RALOX Regimen HAIC in Hepatocellular Carcinoma, sponsored by Guangdong Provincial People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-20.
Sponsored by Guangdong Provincial People's Hospital · Phase 2, Interventional, and Treatment
To evaluate the efficacy and safety of lenvatinib, tislelizumab combined with RALOX regimen HAIC in advanced hepatocellular carcinoma.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 29 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Guangdong Provincial People's Hospital is the lead sponsor of 231 studies on the registry; 101 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Lenvatinib, Tislelizumab Combined with RALOX Regimen HAIC
RALOX Regimen of Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Tislelizumab
Objective Response Rate
The proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time, including cases of complete remission (CR), partial remission (PR) under mRECIST criteria
Time frame: After the first HAIC treatment, until the disease progresses or dies (during the treatment of the patient) or the toxicity is intolerable，through study completion, an average of 12 months
Progression-free survival
The date from the date of admission to the date of the first progression of disease or death of any cause.
Time frame: From date of the first HAIC treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Overall survival
The date from the date of admission to the date of death of any cause
Time frame: Through study completion, up to 24 months
Disease control rate
The percentage of confirmed cases including complete remission (CR), partial remission (PR) and disease stability (SD) among patients with evaluable efficacy
Time frame: From date of the first HAIC treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Adverse Events
Categorized according to NCI Common Toxicity Criteria version 5.0. Summarized in terms of type, severity (grade 1-5), and dose level in tabular format.
Time frame: Until the last medication for 30 days (±7 days) or before the start of other anti-tumor therapy (whichever occurs first).
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Guangdong Provincial People's Hospital