An observational study in Hepatocellular Carcinoma Non-resectable, sponsored by Second Affiliated Hospital of Guangzhou Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by Second Affiliated Hospital of Guangzhou Medical University · Observational
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.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 205 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →Second Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 69 studies on the registry; 49 are open to participants now.
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Patients with large HCC and PVTT.
Exclusion Criteria:
Patients were treated with Len+DEB-TACE+HAIC.
Procedure: Len+DEB-TACE+HAIC
Patients were treated with Len+DEB-TACE.
Procedure: Len+DEB-TACE
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.
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.
Time to progression (TTP)
defined as the time from treatment initiation to the first occurrence of disease progression.
Time frame: 3.5 years
objective response rate (ORR)
defined as the percentage of patients with complete or partial response
Time frame: 3.5 years
Disease control rate (DCR)
defined as the percentage of patients with complete or partial response, or stable disease
Time frame: 3.5 years
overall survival
defined as the time from treatment initiation until death from any reason.
Time frame: 3.5 years
treatment-related adverse events (TRAEs)
assessed based on Common Terminology Criteria for Adverse Events version 5.0
Time frame: 3.5 years
Plan to share: Undecided
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital of Guangzhou Medical University