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bTAE-HAIC Combined With Lenvatinib and Sintilimab for Infiltrative Hepatocellular Carcinoma

ConditionsLiver DiseasesHepatocellular CarcinomaImmunotherapyLenvatinibSintilimab
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

This study intends to evaluate the efficacy and safety of blank- microsphere transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (bTAE-HAIC) plus Lenvatinib and Camrelizumab for patients with infiltrative hepatocellular carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of infiltrative HCC.

Infiltrative HCC was characterized as follows: nonencapsulated arterial phase hyperenhancement; tumor washout in the period of portal phase, and noncircular, ill-defined margin

Age between 18 and 75 years;

The maximum tumor size ≥10 cm, and the total tumor size ≥15 cm;

Disqualifiers

HCC with capsule;

Extrahepatic metastasis >5;

Obstructive PVTT involving the main portal vein.

Serious medical comorbidities.

Trial design

Design model

Single group

Treatments tested in this trial

  • bTAE-HAIC

    Procedure/Surgery

    bTAE procedure was a 2.8-F microcatheter was superselectively inserted into the tumor feeding artery using the coaxial technique. Then blank microspheres were used according to the tumor blood supply vessels (40-120um, 100-300um, 300-500um, 500-700um). The microcatheter was reserved at the proper/left/right hepatic artery according tumor location. After the patient returned to the ward, the following FOLFOX-based regime was intra-arterially administered through the microcatheter. The FOLFOX regimen was administered via the hepatic artery as follows: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1, and 400 mg/m2 leucovorin from hour 2 to 4 on day 1, and 400 mg/m2 fluorouracil bolus at hour 5 on the day 1; and 2400 mg/m2 fluorouracil over 46 h on days 1 and 2.

  • Lenvatinib

    Drug

    12 mg (or 8 mg) once daily (QD) oral dosing.

  • Sintilimab

    Drug

    200mg intravenously every 32 weeks

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: bTAE-HAIC combined with Lenvatinib and SintilimabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

ORR, as determined based on tumor response according to RECIST 1.1

Time frame
6 months

Secondary outcomes

1

Progression free survival (PFS)

PFS is defined as the time from the date of inclusion to the date of the first objectively documented tumor progression or death due to any cause.

Time frame
6 months
2

Overall survival (OS)

OS is the length of time from the date of inclusion until death from any cause.

Time frame
12 months

Other outcomes

Sponsors and contacts

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Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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