Lenvatinib Plus DEB-TACE With/Without FOLFOX-HAIC for Large HCC With PVTT

NCT ID: NCT06265883

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 205 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2022-12-31

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.

Conditions

Hepatocellular Carcinoma Non-resectable

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Len+DEB-TACE+HAIC

Patients were treated with Len+DEB-TACE+HAIC.

Len+DEB-TACE+HAIC

Intervention Type: PROCEDURE

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.

Len+DEB-TACE

Patients were treated with Len+DEB-TACE.

Len+DEB-TACE

Intervention Type: PROCEDURE

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.

Interventions

Len+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.

Intervention Type: PROCEDURE

Len+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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongshan People's Hospital, Guangdong, China

OTHER

Sponsor Role: collaborator

Affiliate Hospital of Guangdong Medical University

UNKNOWN

Sponsor Role: collaborator

Jieyang People's Hospital

OTHER

Sponsor Role: collaborator

Huizhou Municipal Central Hospital

OTHER

Sponsor Role: collaborator

Guangzhou Development District Hospital

UNKNOWN

Sponsor Role: collaborator

Affiliated Hospital of Nanjing University of Chinese Medicine

OTHER

Sponsor Role: collaborator

First People's Hospital of Foshan

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Countries

China

References

Cai M, Liang L, Zhang J, Chen N, Huang W, Guo Y, Hong X, Lin L, Liu Y, Dan C, Deng H, Liu X, Zhou J, Chen Y, Chen H, Zhu K. Lenvatinib plus drug-eluting bead transarterial chemoembolization with/without hepatic arterial infusion chemotherapy for hepatocellular carcinoma larger than 7 cm with major portal vein tumor thrombosis: a multicenter retrospective cohort study. Int J Surg. 2024 Dec 1;110(12):7860-7870. doi: 10.1097/JS9.0000000000001819.

Reference Type: DERIVED

PMID: 38869974 (View on PubMed)

Other Identifiers

MIIR-16-Retro

Identifier Type: -

Identifier Source: org_study_id