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Lenvatinib Plus DEB-TACE and HAIC vs. Lenvatinib Plus DEB-TACE for Large HCC With PVTT

ConditionHepatocellular Carcinoma Non-resectable
Trial statusRecruiting
Trial phasePhase 3
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 transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (Len+DEB-TACE+HAIC) versus lenvatinib plus DEB-TACE (Len+DEB-TACE) for large hepatocellular carcinoma (\> 7cm) with portal vein tumor thrombosis (PVTT).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

a confirmed diagnosis of HCC

the largest intrahepatic lesion >7 cm

presence of PVTT on imaging

tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment

Disqualifiers

Diffuse HCC

accompanied with vena cava tumor thrombus

central nervous system involvement

previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Len+DEB-TACE+HAIC

    Combination product

    For DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session. After each chemoembolization, the microcatheter is reserved at the main hepatic tumor-feeding artery. The FOLFOX-based regimen is intra-arterially administered. During follow-up, the treatment of DEB-TACE and/or HAIC will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination. Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd will be started with 7 days after the first DEB-TACE+HAIC.

  • Len+DEB-TACE

    Combination product

    For DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session. During follow-up, the treatment of DEB-TACE will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination. Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd will be started with 7 days after the first DEB-TACE+HAIC.

Treatment groups

178 Participants
are divided into 2 treatment groups
Group A: Len+DEB-TACE+HAICExperimental treatment 1 intervention
Group B: Len+DEB-TACEActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to progression (TTP)

The time from date of randomization until the first occurrence of disease progression (according to mRECIST).

Time frame
2 years

Secondary outcomes

1

Objective response rate (ORR)

The proportion of patients with the best response of complete response (CR) or partial response (PR) according to mRECIST.

Time frame
2 years
2

Disease control rate (DCR)

The proportion of patients with the best response of CR, PR, or stable disease (SD) according to mRECIST.

Time frame
2 years
3

Overall survival (OS)

The time from date of randomization to death due to any cause.

Time frame
3 years
4

Adverse Events (AEs)

Number of patients with AEs assessed by Common Terminology Criteria for Adverse Events v5.0.

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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