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DEB-TACE+RALOX-HAIC vs DEB-TACE for Large 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 transarterial chemoembolization with drug-eluting beads (DEB-TACE) combined with hepatic artery infusion chemotherapy (HAIC) with oxaliplatin and raltitrexed (RALOX-HAIC) versus DEB-TACE alone for unresectable large hepatocellular carcinoma (HCC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

HCC confirmed by histology/cytology or diagnosed clinically.

At least one measurable intrahepatic target lesion.

The largest tumor size > 7 cm.

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

Disqualifiers

Macrovascular invasion or extrahepatic metastasis.

Diffuse HCC.

Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.

Previous palliative treatments, including TACE, transcatheter arterial embolization, HAIC, radiation therapy, systemic therapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • DEB-TACE+HAIC

    Drug

    CalliSpheres (100-300 µm) loaded with pirarubicin for transarterial chemombolization: Typically, one vial of the beads was loaded with 60 mg pirarubicin. If blushed tumors is still visible after the embolization with one vial of beads, regular microspheres (8spheres) with diameters of 100-700 μm are additionally injected. RALOX-based regimen for hepatic arterial infusion chemotherapy: oxaliplatin, 85 mg/m2 infusion for 2 hours; Raltitrexed, 3 mg/m2 infusion for 0.5 hour.

  • DEB-TACE

    Drug

    CalliSpheres (100-300 µm) loaded with pirarubicin for transarterial chemombolization: Typically, one vial of the beads was loaded with 60 mg pirarubicin. If blushed tumors is still visible after the embolization with one vial of beads, regular microspheres (8spheres) with diameters of 100-700 μm are additionally injected.

Treatment groups

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

Trial outcomes

Primary outcomes

1

Progression free survival (PFS)

The time from date of randomization until the first occurrence of disease progression (according to mRECIST) or death due to any cause, whichever occurs first.

Time frame
3 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
3 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
3 years
3

Overall survival (OS)

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

Time frame
4 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

Zhongshan People's Hospital, Guangdong, China

Collaborator

Guangzhou Development District Hospital

Collaborator

The Affiliated Shunde Hospital of Jinan University

Collaborator

Source ClinicalTrials.gov
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