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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2024-01-01

Brief Summary

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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.

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Detailed Description

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HCC is one of the most common malignant tumors with the worst prognosis. At present, except for liver transplantation, surgical resection is the most effective therapy for patients with HCC. However, many patients are found to have advanced cancer as soon as they were diagnosed and lose the opportunity of radical resection and treatments are limited.More and more clinical research failures have hit the investigators' hard, until a clinical study named IMbrave150, published in the New England Journal of Medicine in 2020. It has opened up a new era of combination therapy, breaking the pattern of only a single mode of advanced liver cancer for more than ten years, making the investigators realize that for the treatment of patients with advanced liver cancer, the single treatment effect is often very limited, and combination therapy is the future.The investigators recent research showed that HAIC Combined With Lenvatinib and Tislelizumab brings good results to patients with advanced HCC.To identify a more effective and safety way for treating potentially resectable HCC patients, this study is designed to compare the safety and efficacy between HAIC-based combination therapy and D-TACE-based combination therapy for those patients in Advanced Unresectable HCC.

Conditions

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Unresectable Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HAIC+lenvatinib+tislelizumab

Hepatic Arterial Infusion Chemotherapy Combined With lenvatinib and tislelizumab

Group Type EXPERIMENTAL

HAIC

Intervention Type DRUG

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.

Lenvatinib

Intervention Type DRUG

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

tislelizumab

Intervention Type DRUG

tislelizumab 200 mg, every 3 weeks.

D-TACE+lenvatinib+tislelizumab

Transarterial chemoembolization with drug-eluting beads Combined With lenvatinib and tislelizumab

Group Type EXPERIMENTAL

D-TACE

Intervention Type 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.

HAIC

Intervention Type DRUG

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.

Lenvatinib

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Lenvatinib

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

Intervention Type DRUG

tislelizumab

tislelizumab 200 mg, every 3 weeks.

Intervention Type DRUG

Other Intervention Names

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D-TACE+lenvatinib+tislelizumab HAIC+Lenvatinib+tislelizumab Targeted therapy PD-1 inhibitors

Eligibility Criteria

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Inclusion Criteria

* Patients with advanced unresectable hepatocellular carcinoma treated by D- TACE, or HAIC combined with Lenvatinib and Tislelizumab as initial treatment
* Age between 18 and 75 years
* Child-Pugh A or B liver function
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Adequate hematologic blood counts (white blood cell count \>3ⅹ109/L, absolute neutrophil count \>1.5ⅹ109/L, platelet count \>10ⅹ109/L, hemoglobin concentration \>85 g/L
* No extrahepatic metastasis

Exclusion Criteria

* Severe underlying cardiac, pulmonary, or renal diseases
* History of a second primary malignant tumor
* Incomplete medical data
* Loss to follow-up.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No