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Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC

ConditionHepatocellular Carcinoma Non-resectable
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital of Guangzhou Medical University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lenvatinib plus SIRT

    Combination product

    Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. QD will be started at 3-7 days after the first SIRT.

  • Lenvatinib

    Drug

    Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. QD.

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: Len+SIRTExperimental treatment 1 intervention
Group B: LENActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR) according to mRECIST

Time frame
3 years

Secondary outcomes

1

Disease control rate (DCR)

The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD) according to mRECIST.

Time frame
3 years
2

Progression free survival (PFS)

The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.

Time frame
3 years
3

Time to response (TTR)

The time from treatment initiation to first tumour remission (mRECIST)

Time frame
3 years
4

Duration of response (DOR)

Time from first tumor response to first disease progression (mRECIST) or death from any cause (whichever occurs first)

Time frame
3 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital of Guangzhou Medical University

Lead sponsor

Source ClinicalTrials.gov
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