HAIC Combine Tislelizumab and Lenvatinib in the Treatment of HCC With Type IV (Vp4) Portal Vein T… (NCT06210334) | Clinical Trial Compass
UnknownPhase 2
HAIC Combine Tislelizumab and Lenvatinib in the Treatment of HCC With Type IV (Vp4) Portal Vein Tumor Thrombus (HAI-TL)
China54 participantsStarted 2024-03
Plain-language summary
To estimate the safety and efficacy of hepatic artery infusion chemotherapy (HAIC) combine Tislelizumab and Lenvatinib (HAI-TIS-LEN) in the Treatment of hepatocellular carcinoma (HCC) with type IV(Vp4) portal vein tumor thrombus (PVTT).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Histologically, cytologically, or clinically confirmed diagnosis of hepatocellular carcinoma (HCC).
✓. Age between 18 and 75 years.
✓. Presence of type 4 portal vein tumor thrombosis (PVTT).
✓. Child-Pugh A or B liver function.
✓. Eastern Cooperative Group performance status (ECOG) score of 0-2.
✓. Satisfactory blood, liver, and kidney function parameters, including:
✓. Ability to comprehend the protocol and provide informed consent by signing a written document.
Exclusion criteria
✕. History of a second primary malignant tumor.
✕. Severe dysfunction of the heart, kidneys, or other organs.
✕. Evidence of hepatic decompensation, including ascites, active gastrointestinal bleeding, or hepatic encephalopathy.
✕. Pregnancy or lactation.
✕. Known history of HIV.
✕. History of organ allograft.
✕. Known or suspected allergy to investigational agents or any agent administered in conjunction with this trial.
What they're measuring
1
Overall Survival (OS)
Timeframe: From the date of treatment initiation until the date of death from any cause, assessed up to 60 months.