Second Affiliated Hospital of Guangzhou Medical University
Phase
Phase 3
Started
2022-11-02
Last updated
2022-11-08
Condition(s) studied
Hepatocellular Carcinoma Non-resectable
Investigational drug(s) / intervention(s)
Lenvatinib Plus I-125 Seed BrachytherapyLenvatinib
Lenvatinib Plus I-125 Seed Brachytherapy: Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight \< 60 kg, 8mg P.O. QD) will be administered to the patients. Iodion-125 seeds will be implanted into the the target lesions (viable intrahepatic tumor and/or vascular tumor thrombus) under CT guidance according to the pre-operative planning within 7 days after lenvatinib administration. Iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.
Lenvatinib: Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight \< 60 kg, 8mg P.O. QD) will be administered to the patients.
Study summary
This study is conducted to evaluate the efficacy and safety of lenvatinib plus iodine-125 seed brachytherapy (Len-I) compared with lenvatinib (Len) alone for patients with hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization (TACE).
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* HCC confirmed by histopathology and/or cytology, or diagnosed clinically
* 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
* Life expectancy of at least 3 months
Exclusion Criteria:
* Extrahepatic metastasis
* Tumor thrombus involving main portal vein or both the first left and right branch of portal vein
* Vena cava invasion
* Patients who received prior systemic therapy, immunotherapy, hepatic arterial infusion chemotherapy (HAIC) or radiotherapy for HCC
* History of organ and cell transplantation
* History of bleeding from esophagogastric varices
* History of hepatic encephalopathy
* Hematologic examination: platelets \<50×10\^9/L
* Prothrombin time prolongation ≥ 4s
* Severe organ (heart, lung, kidney) dysfunction
* History of malignancy other than HCC
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
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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