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New treatment option for Hepatocellular Carcinoma
Official title Lenvatinib, Sintilimab Plus SIRT for Unresectable HCC
ClinicalTrials.gov ID: NCT05992584
What this study is testing
What is Lenvatinib, sintilimab plus SIRT?
Lenvatinib, sintilimab plus SIRT is an investigational medicine, being studied as a potential treatment for hepatocellular carcinoma.
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, sintilimab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC).
- Phase 2: a mid-size study of how well it works
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
- Unresectable HCC (BCLC stage B/C) with diagnosis confirmed by histology/cytology or clinically
- At least one measurable untreated lesion
- Intrahepatic tumors can be treated with 1-2 session of SIRT
- Child-Pugh score 5-7
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
You likely can't join if
- tumor extent ≥70% liver occupation
- Tumor thrombus involving main portal vein or both the first left and right branch of portal vein
- Vena cava invasion
- Central nervous system metastasis
- Metastatic disease that involves major airways or blood vessels
- Patients who previously received hepatic arterial infusion chemotherapy (HAIC), transarterial chemoembolization (TACE), transarterial embolization...
See the full eligibility criteria
- Unresectable HCC (BCLC stage B/C) with diagnosis confirmed by histology/cytology or clinically
- At least one measurable untreated lesion
- Intrahepatic tumors can be treated with 1-2 session of SIRT
- Child-Pugh score 5-7
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Life expectancy of at least 3 months
- Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA\<10\^3 IU/mL
- Patients with hepatitis C need to finish the anti-HCV treatment
- tumor extent ≥70% liver occupation
- Tumor thrombus involving main portal vein or both the first left and right branch of portal vein
- Vena cava invasion
- Central nervous system metastasis
- Metastatic disease that involves major airways or blood vessels
- Patients who previously received hepatic arterial infusion chemotherapy (HAIC), transarterial chemoembolization (TACE), transarterial embolization (TAE), radiotherapy, systemic therapy, or immunotherapy for HCC
- History of organ and cell transplantation
- Prior esophageal and/or gastric varices bleeding
- History of hepatic encephalopathy
- Peripheral blood white blood cell count\<3×10\^9/L, platelet count\<50×10\^9/L
- Prolongation of prothrombin time ≥ 4 seconds
- Severe organ dysfunction (heart, lungs, kidneys)
- History of malignancy other than HCC
- HBsAg and anti-HCV antibody positive concurrently
- Human immunodeficiency virus (HIV) infected
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.