Hepatocellular Carcinoma Non-resectable
Conditions
Keywords
Hepatocellular Carcinoma, Lenvatinib, transarterial chemoembolization, drug-eluting bead, hepatic arterial infusion chemotherapy, portal vein tumor thrombosis
Brief summary
This multicenter retrospective study evaluated consecutive patients with large HCC and PVTT who received lenvatinib plus DEB-TACE with/without FOLFOX-HAIC between July 2019 and June 2021. Tumor response, time to progression (TTP), overall survival (OS), and treatment-related adverse events (TRAEs) were compared between the two groups.
Detailed description
Consecutive patients with large HCC and PVTT treated with lenvatinib plus drug-eluting bead transarterial chemoembolization (DEB-TACE) and hepatic arterial infusion chemotherapy (HAIC) with oxaliplatin, fluorouracil and leucovorin (Len+DEB-TACE+HAIC) or lenvatinib plus DEB-TACE (Len+DEB-TACE) from July 2019 to June 2021 were screened. Tumor response was evaluated according to modified Response Evaluation Criteria in Solid Tumors (mRECIST). Clinical outcomes, including tumor response, TTP, OS, and TRAEs were compared between the two groups.
Interventions
PROCEDURELen+DEB-TACE+HAIC
Patients received TACE with drug-eluting beads and FOLFOX-HAIC. DEB-TACE and/or HAIC was repeated for viable tumors demonstrated by follow-up imaging in patients without worsening liver function or contraindications. Lenvatinib was orally administered at a dose of 12 mg/day (bodyweight 60 kg) or 8mg/day (bodyweight \<60 kg). It was initiated within 7 days after the first DEB-TACE or DEB-TACE+HAIC and continued until unacceptable toxicity or disease progression occurred.
PROCEDURELen+DEB-TACE
Patients received TACE with drug-eluting beads. DEB-TACE was repeated for viable tumors demonstrated by follow-up imaging in patients without worsening liver function or contraindications. Lenvatinib was orally administered at a dose of 12 mg/day (bodyweight 60 kg) or 8mg/day (bodyweight \<60 kg). It was initiated within 7 days after the first DEB-TACE or DEB-TACE+HAIC and continued until unacceptable toxicity or disease progression occurred.
Sponsors
Zhongshan People's Hospital, Guangdong, China
Affiliate Hospital of Guangdong Medical University
Jieyang People's Hospital
Huizhou Municipal Central Hospital
Guangzhou Development District Hospital
Affiliated Hospital of Nanjing University of Chinese Medicine
First People's Hospital of Foshan
Second Affiliated Hospital of Guangzhou Medical University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* a confirmed diagnosis of HCC * the largest intrahepatic lesion \>7 cm * presence of major PVTT on imaging * Eastern Cooperative Oncology Group performance status ≤1 * Child-Pugh class A/B * adequate hematologic and organ function, with leukocyte count 3.0 109/L, neutrophil count 1.5 109/L, platelet count 75 109/L, hemoglobin 85 g/L, alanine transaminase and aspartate transaminase 5 upper limit of the normal, creatinine clearance rate 1.5 upper limit of the normal, and prothrombin time prolongation \<4 s
Exclusion criteria
* incomplete medical records * central nervous system involvement * previous treatment with transarterial embolization, TACE, HAIC, radiotherapy, or systemic therapy * history of malignancies other than HCC * history of organ transplantation * severe cardiac, pulmonary or renal dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to progression (TTP) | 3.5 years | defined as the time from treatment initiation to the first occurrence of disease progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate (ORR) | 3.5 years | defined as the percentage of patients with complete or partial response |
| Disease control rate (DCR) | 3.5 years | defined as the percentage of patients with complete or partial response, or stable disease |
| overall survival | 3.5 years | defined as the time from treatment initiation until death from any reason. |
| treatment-related adverse events (TRAEs) | 3.5 years | assessed based on Common Terminology Criteria for Adverse Events version 5.0 |
Countries
China
Outcome results
None listed