๐ฌIn plain words
What the trial is, and whether it could suit you
This study is conducted to evaluate the efficacy and safety of lenvatinib, sintilimab plus TACE (Len-Sin-TACE) compared with lenvatinib plus TACE (Len-TACE) for patients with advanced hepatocellular carcinoma (HCC).
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Advanced HCC (BCLC stage C, or CNLC IIIa and IIIb ) with diagnosis confirmed by histology/cytology or clinically
* 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
* Life expectancy of at least 3 months
Exclusion Criteria:
* Obstructive portal vein tumor thrombus involving both the left and right portal vein or main portal vein without collateral vessels
* Vascular invasion involving inferior vena cava
* Central nervous system metastasis
* Patients who received prior systemic therapy, immunotherapy, TACE, transcatheter arterial radioembolization (TARE), transcatheter arterial embolization (TAE), hepatic arterial infusion chemotherapy (HAIC) or radiation therapy for HCC
* History of organ and cell transplantation
* History of bleeding from esophageal and gastric varices
* History of hepatic encephalopathy
* hematologic examination: white blood cell count \<3.0ร10\^9/L, platelets \<50ร10\^9/L
* Prothrombin time prolongation โฅ 4s
* Severe organ (heart, lung, kidney) dysfunction
* History of malignancy other than HCC
* Active hepatitis B or C infection; hepatitis B virus (HBV) DNA \> 1000 copies/ml; hepatitis C virus (HCV) RNA \> 1000 copies/ml. Those who possess the indicators lower than the above criteria after nucleotide antiviral treatment can be enrolled
๐
What it tests
- Lenvatinib, sintilimab plus TACE
- Lenvatinib plus TACE
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.