bTAE-HAIC Combined With System Therapy for Intermediate-advanced Huge HCC

ConditionsLiver Diseases Hepatocellular Carcinoma Immunotherapy Camrelizumab Lenvatinib

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 intermediate-advanced huge hepatocellular carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of HCC.

Age between 18 and 75 years;

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

Intermediate-advanced huge HCC, advanced HCC with PVTT type I or type II or limited metastases (≤5).

Disqualifiers

Diffuse HCC;

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.
Camrelizumab
Drug
200mg intravenously every 2 weeks

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: bTAE-HAIC combined with Lenvatinib and CamrelizumabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

Objective response rate (ORR)

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

Time frame

6 months

Secondary outcomes

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

Other outcomes

Overall survival (OS)

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

Time frame

12 months

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov

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