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Compares treatment options for Hepatocellular Carcinoma Non-resectable
Official title Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC
ClinicalTrials.gov ID: NCT06904196
What this study is testing
What is Lenvatinib plus SIRT?
Lenvatinib plus SIRT is an investigational medicine, being studied as a potential treatment for hepatocellular carcinoma non-resectable.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is conducted to evaluate the efficacy and safety of lenvatinib plus SIRT (LEN+SIRT) compared with lenvatinib (LEN) alone for patients with hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization (TACE).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Pathologically confirmed or clinically diagnosed HCC
- Diagnosis of HCC with TACE refractoriness according to the criteria proposed by Japan Society of Hepatology (2021)
- Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included
- At least one measurable intrahepatic target lesion
- Child-Pugh class A/B
You likely can't join if
- Extrahepatic metastasis
- Tumor thrombus involving main portal vein or both the first left and right branches of portal vein
- Vena cava invasion
- Patients who received prior hepatic arterial infusion chemotherapy (HAIC), radiotherapy, or systemic therapy, for HCC
- History of organ and cell transplantation
- History of esophageal or gastric variceal bleeding
See the full eligibility criteria
- Pathologically confirmed or clinically diagnosed HCC
- Diagnosis of HCC with TACE refractoriness according to the criteria proposed by Japan Society of Hepatology (2021)
- Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included
- At least one measurable intrahepatic target lesion
- Child-Pugh class A/B
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Tumor extent \<70% liver occupation
- Candidates for SIRT must be confirmed suitable for SIRT after evaluation (including SPECT/CT evaluation after arterial perfusion with 99Tc-MAA)
- Adequate organ and hematologic function with platelet count ≥50×10\^9/L, leukocyte \>3.0×10\^9/L, Neutrophil count ≥1.5×10\^9/L, haemoglobin ≥85 g/L, ALT and AST≤5×ULN, albumin ≥28 g/L, total bilirubin ≤3× ULN...
- Life expectancy of at least 3 months
- Extrahepatic metastasis
- Tumor thrombus involving main portal vein or both the first left and right branches of portal vein
- Vena cava invasion
- Patients who received prior hepatic arterial infusion chemotherapy (HAIC), radiotherapy, or systemic therapy, for HCC
- History of organ and cell transplantation
- History of esophageal or gastric variceal bleeding
- History of hepatic encephalopathy
- History of other malignancies
- Human immunodeficiency virus infection
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.