Hepatocellular Carcinoma Non-resectable
Conditions
Keywords
hepatocellular carcinoma, Lenvatinib, Yttrium-90
Brief summary
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).
Detailed description
This is a prospective, non-randomized controlled trial to evaluate the efficacy and safety of LEN+SIRT versus LEN alone for patients with TACE-refractory HCC. 78 patients (39 in each arm) with TACE-refractory HCC will be enrolled in this study. The patients will receive either LEN+SIRT or LEN. Lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight \< 60 kg, 8mg P.O. QD) will be administered to the patients and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. For patients in the LEN+SIRT arm, lenvatinib will be started at 3-7 days after SIRT. The primary end point of this study is objective response rate (ORR). The secondary endpoints are disease control rate (DCR), progression-free survival (PFS), time to response (TTR), duration of response (DOR), overall survival (OS), and adverse events (AEs).
Interventions
COMBINATION_PRODUCTLenvatinib plus SIRT
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. QD will be started at 3-7 days after the first SIRT.
DRUGLenvatinib
Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. QD.
Sponsors
Second Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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, creatinine≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds * Life expectancy of at least 3 months
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 3 years | The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR) according to mRECIST |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | 3 years | The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first. |
| Time to response (TTR) | 3 years | The time from treatment initiation to first tumour remission (mRECIST) |
| Disease control rate (DCR) | 3 years | The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD) according to mRECIST. |
| Overall survival (OS) | 4 years. | The time from date of treatment initiation to death due to any cause |
| Adverse Events (AEs) | 3 years. | Number of patients with AEs assessed by NCI CTCAE v5.0. |
| Duration of response (DOR) | 3 years. | Time from first tumor response to first disease progression (mRECIST) or death from any cause (whichever occurs first) |
Countries
China
Contacts
Primary ContactMingyue Cai, Dr.
Backup ContactMingyue Cai, Dr.
Outcome results
None listed