Second Affiliated Hospital of Guangzhou Medical University
Phase
Phase 3
Started
2022-11-02
Last updated
2023-05-31
Condition(s) studied
Hepatocellular Carcinoma Non-resectable
Investigational drug(s) / intervention(s)
Lenvatinib, sintilimab plus TACELenvatinib plus TACE
Lenvatinib, sintilimab plus TACE: Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd and sintilimab (200mg I.V. q3w) will be started at 3-7 days after the first TACE. TACE will be repeated if clinically indicated. Treatment of sintilimab will last up to 24 months. Patients will be allowed to have lenvatilib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.
Lenvatinib plus TACE: Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd will be started at 3-7 days after the first TACE. TACE will be repeated if clinically indicated. The interruption, dose reduction and discontinuation of lenvatinib depended on the presence and severity of toxicities according to the drug directions.
Study summary
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 \<3.0×10\^9/L, platelets \<50×10\^9/L
* Prothrombin time prolongation ≥ 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
Primary outcome measure(s)
Overall survival (OS) — 4 years The time from date of randomization to death due to any cause.
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou
Guangdong
Recruiting
More Second Affiliated Hospital of Guangzhou Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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