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dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Hepatocellular Carcinoma

ConditionsAdvanced Hepatocellular CarcinomaAtezolizumabBevacizumabChemotherapy
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 drug-eluting transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (dTACE-HAIC) plus Bevacizumab and Atezolizumab 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;

Intermediate-advanced huge HCC, advanced HCC with PVTT type I-III

Disqualifiers

Diffuse HCC;

Extrahepatic metastasis >5;

Obstructive PVTT involving mesenteric vena cava (PVTT IV).

Serious medical comorbidities.

Trial design

Design model

Single group

Treatments tested in this trial

  • dTACE-HAIC

    Procedure/Surgery

    dTACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then drug-eluting microspheres were used (100-300um). 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. Hepatic arterial infusion chemotherapy administration of oxaliplatin, fluorouracil, and leucovorin via the tumor feeding arteries every 4 weeks

Treatment groups

27 Participants
are divided into 1 treatment group
Group A: dTACE-HAIC plus Bevacizumab and AtezolizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response.

Time frame
12 months

Secondary outcomes

1

Progression-Free-Survival (PFS)

PFS is the length of time from the date of inclusion until tumor progression.

Time frame
12 months
2

Overall survival (OS)

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

Time frame
24 months

Other outcomes

Sponsors and contacts

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Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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