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HAIC+Lenvatinib+Tislelizumab vs D-TACE+Lenvatinib+Tislelizumab for Unresectable HCC

NCT05582278 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-10-17

No results posted yet for this study

Summary

Drug-eluting Bead-Transarterial chemoembolization (D-TACE) is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients. While a number of studies demonstrate poor effect of D-TACE for patients in Advanced Unresectable HCC. The investigators previous study also revealed similar results in Advanced Unresectable HCC patients treated with D-TACE. Recently, the investigators previous study demonstrated that, compared with D-TACE, hepatic arterial infusion chemotherapy (HAIC) may improve tumor response in Advanced Unresectable HCC. Thus, the investigators carried out this prospective nonrandomized control to demonstrate the superiority of HAIC-based combination therapy over D-TACE-based combination therapy.

Conditions

Interventions

DRUG

D-TACE

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.

DRUG

HAIC

FOLFOX-based regimen for hepatic arterial infusion chemotherapy: oxaliplatin, 100 mg/m2 infusion for 2 hours; calcium levofolinate, 200 mg/m2 infusion for 1 hours; and 5-FU, 400 mg/m2 bolus infusion and then 2400 mg/m2 continuous infusion over 46 h.

DRUG

Lenvatinib

12 mg/d for bodyweight ⩾ 60 kg or 8 mg/d for bodyweight \<60 kg

DRUG

tislelizumab

tislelizumab 200 mg, every 3 weeks.

Sponsors & Collaborators

  • Wen Li

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2024-01-01
Completion
2024-01-01

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05582278 on ClinicalTrials.gov